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Check your vial. Know your next step.
Compounded GLP-1 recall list, October 2026: is your tirzepatide vial on it?
By the NexLife Medical Team · Medically reviewed by Adam Kennah, MD · Updated
FDA classified three recalls of compounded
- Lot numbers and dates from FDA’s records, in one table
- Five steps if your vial matches, or you aren’t sure
- What a sterility recall means for your vial, in FDA’s words
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At a glance
What was in the October 2026 GLP-1 recall, and what should you do?
The October recalls in six rows, from FDA’s recall records, checked November 1, 2026.
| Question | Short answer |
|---|---|
| What was recalled? | Compounded tirzepatide and semaglutide injections from three companies: Apothecary Pharma, Carolina Infusion and Houston Rx |
| How serious is it? | Class II, FDA’s middle risk level. FDA classified all three from October 8 to 13, 2026 |
| Why? | FDA’s stated reason for each: lack of assurance of sterility |
| Who started them? | The companies. FDA’s records code each one “Voluntary: Firm initiated” |
| What should you do? | Check the pharmacy and lot number on your label. If they match, or you aren’t sure, ask your prescriber or pharmacist before you use it |
| Does it affect NexLife? | No. Neither NexLife partner pharmacy, Absolute Pharmacy (Lutz, FL) or Boudreaux’s New Drug Store (Lake Charles, LA), is named in FDA’s records for these recalls (checked November 1, 2026) |
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Key takeaways
- Three recalls, all Class II. FDA classified recalls of compounded
GLP-1 injections from October 8 to 13, 2026. - The companies: Apothecary Pharma, Carolina Infusion and Houston Rx, for compounded tirzepatide and semaglutide injections.
- FDA’s reason: lack of assurance of sterility. A documentation issue is some companies’ explanation, not FDA’s.
- Check your label: if the pharmacy and lot number match, or you aren’t sure, ask your prescriber or pharmacist first.
- Signs of infection? Spreading redness, warmth, swelling or pain where you injected, or fever with chills: get care right away.
- NexLife’s pharmacies aren’t named in these recalls (checked November 1, 2026). Compounded tirzepatide at NexLife: $139 a month on the 12-month plan.
What was recalled
Which compounded GLP-1s were recalled?
FDA classified three recalls of compounded
| Recalling firm | What was recalled | Lot numbers and dates | FDA’s reason, and when |
|---|---|---|---|
| Classified Class II in October 2026 | |||
| Apothecary Pharma LLCCary, NC | Tirzepatide injection, 18 mg/mL, in a 4 mL multi-dose vial (NDC | Lots | “Lack of Assurance of Sterility.” Started September 24; classified Class II on October 8, 2026. Customers were told by letter. |
| Carolina Infusion, LLCRidgeland, SC | Single-use syringes, most filled for one patient’s prescription: tirzepatide with cyanocobalamin (B12) at 26/2, 64/2, 76/2 and 85/2 mg/mL; tirzepatide 26 mg/mL; semaglutide with B12 at 3/2 and 9/2 mg/mL; and semaglutide 3 mg/mL. | Lot numbers look like 07212026@18. Beyond-use dates September 4 to October 16, 2026, so all of them have passed. | Lack of assurance of sterility, which FDA’s record links to making the medicine with bacteriostatic water, and to processing equipment. Started September 10; classified Class II on October 8, 2026. Customers were told by email. |
| Houston Rx LLCHouston, TX | Tirzepatide with niacinamide, 20 mg/2 mg per mL, in a 2 mL vial. 64 vials. | Lot | “Lack of assurance of sterility.” Started September 25; classified Class II on October 13, 2026. |
| Earlier, and separate: classified Class II in August 2026 | |||
| Apollo Care, LLCColumbia, MO | Semaglutide in multi-dose vials of several strengths, some with glycine. | Lot numbers such as | “Presence of Particulate Matter,” identified as nylon/polyamide and silk/proteinaceous-type material. Started July 29; classified Class II on August 7, 2026. Customers were told by email. |
Swipe the table sideways to see every column.
From FDA’s recall records: openFDA’s drug enforcement data (updated October 21, 2026), checked November 1, 2026.
- Who started them: the companies. FDA’s records code each one “Voluntary: Firm initiated,” so none was requested by FDA.
- Where they went: distributed across the U.S., per FDA’s records.
- Why you’re hearing about them now: the Apothecary and Carolina Infusion recalls appeared in FDA’s Enforcement Report of October 14, 2026, Houston Rx’s in the report of October 21, and the recalls reached the national news from October 19 to 23.
Updated: last checked November 1, 2026, against FDA’s recall records.
Timeline
When did each compounded GLP-1 recall happen?
Every date from FDA’s recall records, newest first.
Houston Rx’s recall appears in FDA’s weekly Enforcement Report. FDA’s recall records
Apothecary Pharma’s and Carolina Infusion’s recalls appear in FDA’s Enforcement Report. FDA’s recall records
FDA classifies Houston Rx’s recall of tirzepatide with niacinamide as Class II. FDA’s recall records
FDA classifies Apothecary Pharma’s tirzepatide vials and Carolina Infusion’s syringes as Class II. FDA’s recall records
The companies start their recalls: Carolina Infusion on September 10, Apothecary Pharma on September 24 and Houston Rx on September 25. FDA’s recall records
FDA classifies Apollo Care’s earlier, separate recall of semaglutide vials as Class II. FDA’s record
Vial safety
Are compounded tirzepatide vials safe after the October recalls?
The October recalls of compounded tirzepatide cover specific lots. FDA classified all three as Class II, its middle risk level. In FDA’s words, using a Class II drug “may cause temporary health consequences but the probability of a serious health issue is remote.” FDA’s records give no instructions for patients. So check your lot before your next dose.
What a sterility recall means
FDA’s records give the same reason for all three October recalls: lack of assurance of sterility. That means there’s no assurance the medicine is sterile. The records don’t say whether contamination was found. As of October 23, no illnesses had been linked to the Apothecary Pharma recall, NewsNation reported.
Why the advice you’ve seen differs
Reports differed. FOX TV stations told readers to “stop using any affected products and contact their pharmacist or prescriber for guidance” (October 21), and NewsNation said the same (October 23). But neither FDA nor Apothecary had issued a public statement on what to do with affected vials, USA Today reported, and NewsNation reported that FDA hadn’t released official instructions.
What some companies are saying. NewLife Rx, a fulfillment service that distributed some of the recalled Apothecary vials, told some customers that Apothecary called it a documentation issue, USA Today reported. That’s the companies’ explanation. FDA’s stated reason is “Lack of Assurance of Sterility.”
FDA’s own position. FDA’s records for these recalls don’t tell patients to stop, or to keep going. Its general advice for Class II recalls, which it says are “generally conducted at the retail level,” is this:
“For class II and III recalls, consumers can generally continue taking the medicine unless the recalling company provides other instructions. In some instances, stopping your medicine may be more harmful to your health than continuing to take the recalled medicine. Talk to your doctor or pharmacist if you have questions or concerns about your medicine.”
So should you stop? Check your lot first. If it matches, or you aren’t sure, don’t use it until you’ve talked with your prescriber or pharmacist. They can weigh FDA’s point about stopping for you. If your lot isn’t on FDA’s list, these recalls don’t cover your vial.
How to check your vial
FDA’s advice is to “check the lot number on the label of your medicine to see if it matches the lot number of the recalled medicine in the notification.” Your label also names the pharmacy that made it and gives a beyond-use date. Apothecary Pharma’s recalled vials carry NDC
FDA’s rules for any multi-dose vial
These apply whether or not your vial is recalled. In FDA’s words: “Generally, FDA recommends that vials containing multiple doses of sterile medications be used within 28 days after the first use because there is an increased risk of contamination after 28 days.” If medicine is left after that, FDA recommends consumers:
- “Discard the vial within 28 days after the first use, even if medication remains in the vial. Do not continue using medication from the vial after 28 days, even if instructions from the compounder say the medication can be used for longer than 28 days.”
- “Always use a new, sterile needle and syringe for each dose. Reusing needles or syringes can result in contamination of the medication.”
FDA also recommends that patients not use “any injectable
From FDA’s page on unapproved
When to call your prescriber or pharmacy
Call your prescriber, the pharmacy that made your vial or the telehealth company you got it through if:
- Your lot matches a recalled lot, or you can’t tell.
- It arrived warm, or without enough refrigeration.
- It looks different from what you’ve had before, or its packaging is broken, damaged or missing instructions for use.
- The label looks wrong, with spelling errors or a wrong pharmacy address.
FDA lists the last two among its warning signs. For signs of an infection where you injected, get medical care right away (step 4).
How to report a problem
FDA asks patients to report “adverse events or quality problems” with any medicine to its MedWatch program, like a reaction or a vial that arrived warm. Report online at fda.gov/medwatch, which FDA calls “the quickest and most direct route,” or call
What to do
What to do if your GLP-1 vial might be recalled
Start with your label. Here’s what to do, in order.
Find the pharmacy and the lot number
Both are on the label of your vial or syringe. Take a photo of the label, so you have it handy when you call.
Compare them with the table
Look for the pharmacy name first: Apothecary Pharma, Carolina Infusion, Houston Rx or Apollo Care. If it matches, check the lot number one character at a time.
If it matches, or you aren’t sure, ask first
Don’t use it until you’ve talked with your prescriber or pharmacist. FDA also suggests asking the pharmacy that made it, or the telehealth company you got it through, about anything on the label.
Get care for signs of infection
Where you injected, watch for redness that spreads, warmth, swelling, or pain or tenderness. Get medical care right away for any of these, or for a fever with chills (MedlinePlus).
Report problems to FDA
Tell FDA’s MedWatch program about a side effect or a problem with the medicine: online at fda.gov/medwatch, or by phone at
1-800-FDA-1088 .
Class II
What does a Class II recall mean for you?
It’s the middle of FDA’s three risk levels. FDA’s general rule is that patients can keep using the medicine unless the company or FDA says otherwise. These recalls are about sterility, though, so check your lot and ask first.
Here’s FDA’s definition of a Class II recall:
“Using the drug may cause temporary health consequences but the probability of a serious health issue is remote. These recalls are generally conducted at the retail level, and patients and consumers can continue using the medicine unless otherwise directed by the recalling company or FDA.”
What FDA says to do about a Class II recall, and why the news gave different advice, is in Vial safety above.
Step by step
How do you check and use a compounded GLP-1 vial, step by step?
FDA’s rules for any multi-dose vial, recalled or not, in the order you’ll need them.
- Check it the day it arrives. Don’t use an injectable GLP-1 that arrives warm or without enough refrigeration, FDA says. Call your prescriber or the company you got it through; if that’s NexLife, call or text (949) 818-8000, 24/7.
- Read the label. It names the pharmacy, the lot number and a beyond-use date; compare the lot with the recall table. Spelling errors or a wrong pharmacy address are reasons to call first.
- Use a new needle and syringe every time. FDA says to use a new, sterile needle and syringe for each dose: reusing them can contaminate the medicine.
- Discard it 28 days after first use. FDA recommends throwing a multi-dose vial away within 28 days after you first use it, even if medicine is left or the compounder’s instructions say it lasts longer.
- Watch the spot where you injected. Spreading redness, warmth, swelling, or pain or tenderness, or a fever with chills: get medical care right away, then report it to FDA’s MedWatch at 1-800-FDA-1088.
From FDA’s page on unapproved GLP-1 drugs, and MedlinePlus for signs of infection.
FDA status
Are compounded GLP-1s FDA-approved?
No. Compounded
In FDA’s words:
“This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.”
Reports to FDA. As of May 31, 2026, FDA had received 990 reports of adverse events associated with compounded semaglutide, and more than 730 associated with compounded tirzepatide. FDA notes it can’t always tell whether the drug caused the problem. It also says adverse events from compounded semaglutide and tirzepatide are likely underreported, since state-licensed pharmacies that aren’t outsourcing facilities don’t have to report them to FDA.
At NexLife
Does the compounded GLP-1 recall affect NexLife?
No. Prescriptions through NexLife are filled by Absolute Pharmacy (Lutz, FL) or Boudreaux’s New Drug Store (Lake Charles, LA), and neither is named in FDA’s records for the Apothecary Pharma, Carolina Infusion, Houston Rx or Apollo Care recalls (checked November 1, 2026).
Questions about your vial come to us. If you were prescribed through NexLife, call or text
Compounded, not FDA-approved. A licensed provider prescribes it only when it offers a significant difference for you.
A note on names. NewLife Rx, the fulfillment service that distributed some of the recalled Apothecary vials, is a different company from NexLife. Several companies have similar names, and it’s an easy mix-up.
Vial math
How many units is your tirzepatide or semaglutide dose?
On a compounded vial, the units depend on its strength. Here are the label doses at example strengths, with the math to check your own.
Tirzepatide
| Dose | mL at 25 mg/mL | Units (U-100) | On the label |
|---|---|---|---|
| 2.5 mg | 0.1 mL | 10 units | Starting dose, for 4 weeks |
| 5 mg | 0.2 mL | 20 units | A maintenance dose |
| 7.5 mg | 0.3 mL | 30 units | A step up |
| 10 mg | 0.4 mL | 40 units | A maintenance dose |
| 12.5 mg | 0.5 mL | 50 units | A step up |
| 15 mg | 0.6 mL | 60 units | The maximum, and a maintenance dose |
The math: mL = dose ÷ strength (mg per mL), and units = mL × 100. At 25 mg/mL, 10 mg is 10 ÷ 25 = 0.4 mL, or 40 units.
Semaglutide
| Weeks | Weekly dose | At 2.5 mg/mL | At 5 mg/mL |
|---|---|---|---|
| 1 to 4 | 0.25 mg | 0.1 mL (10 units) | 0.05 mL (5 units) |
| 5 to 8 | 0.5 mg | 0.2 mL (20 units) | 0.1 mL (10 units) |
| 9 to 12 | 1 mg | 0.4 mL (40 units) | 0.2 mL (20 units) |
| 13 to 16 | 1.7 mg | 0.68 mL (68 units) | 0.34 mL (34 units) |
| 17 onward | 2.4 mg | 0.96 mL (96 units) | 0.48 mL (48 units) |
The math: mL = dose ÷ strength (mg per mL); units = mL × 100. At 2.5 mg/mL, 1 mg is 1 ÷ 2.5 = 0.4 mL, or 40 units. At 5 mg/mL, the same 1 mg is 0.2 mL, or 20 units.
25 mg per mL is an example only: it’s the strength of the 15 mg multi-dose vial on Zepbound’s label (15 mg per 0.6 mL). Read the strength on your own vial’s label; your provider sets your dose, in steps at least 4 weeks apart. Every step: the tirzepatide dosage chart. Both strengths are examples only. The same dose is a different number of units at a different strength, so read the strength on your own vial’s label. Your prescription sets your dose and schedule, which may differ from these label steps. Every step: the semaglutide dosage chart.
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Compounded GLP-1 recalls: your questions
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Which compounded GLP-1s were recalled in October 2026?
FDA classified three recalls of compounded
Is compounded tirzepatide safe after the recall?
The recalls cover specific lots, not compounded tirzepatide as a whole. FDA classified all three as Class II, its middle risk level, where it calls the probability of a serious health issue “remote.” Compounded tirzepatide isn’t FDA-approved, so FDA doesn’t review it before it’s sold. If your lot matches, or you aren’t sure, ask your prescriber or pharmacist first.
How do I know if my compounded tirzepatide is recalled?
Check the pharmacy name and lot number on your label against FDA’s list. Apothecary Pharma’s recalled 18 mg/mL vials carry lots
Can I keep using a vial from a Class II recall?
Check your lot first. If it matches, or you aren’t sure, ask your prescriber or pharmacist before using it. For Class II recalls, FDA says patients “can continue using the medicine unless otherwise directed by the recalling company or FDA.” But these recalls are about sterility, and FDA’s records gave patients no instructions as of November 1, 2026.
Why were these compounded GLP-1s recalled?
FDA’s stated reason for all three is “lack of assurance of sterility”: there’s no assurance the medicine is sterile. For Carolina Infusion, FDA’s record links it to making the medicine with bacteriostatic water, and to processing equipment. Some companies have told customers it was a documentation issue; that’s their explanation, not FDA’s.
What does a Class II recall mean?
FDA says using a Class II drug “may cause temporary health consequences but the probability of a serious health issue is remote.” Class I is the most serious level and Class III the least. FDA also says: “Talk to your doctor or pharmacist if you have questions or concerns about your medicine.”
What are the signs of an infection after a GLP-1 shot?
Watch the spot where you injected for redness that spreads, warmth, swelling, or pain or tenderness, and watch for a fever with chills, as MedlinePlus lists them. Get medical care right away if you notice any of these. FDA says to contact your health care professional first, then report the reaction to MedWatch, at fda.gov/medwatch or
How long can I use a multi-dose vial of compounded tirzepatide or semaglutide?
FDA recommends throwing a multi-dose vial away within 28 days after you first use it, even if medicine is left, and even if the compounder’s instructions say it lasts longer. FDA also says to use a new, sterile needle and syringe for every dose, and not to use an injectable
Was Apollo Care’s semaglutide recalled too?
Yes, in an earlier, separate recall. Apollo Care, LLC, of Columbia, MO, recalled semaglutide in multi-dose vials of several strengths, some with glycine, for “Presence of Particulate Matter,” identified as nylon/polyamide and silk/proteinaceous-type material. It began July 29 and was classified Class II on August 7, 2026. FDA’s record lists every lot.
Is NewLife Rx part of NexLife?
No. NewLife Rx, the fulfillment service that distributed some of the recalled Apothecary vials, is a different company from NexLife. Prescriptions through NexLife are filled by Absolute Pharmacy (Lutz, FL) or Boudreaux’s New Drug Store (Lake Charles, LA). Neither is named in FDA’s records for these recalls (checked November 1, 2026).
Has anyone gotten sick from the recalled compounded tirzepatide?
No illnesses had been linked to the Apothecary Pharma recall as of October 23, 2026, NewsNation reported. FDA’s reason for all 3 October recalls is lack of assurance of sterility, and its records don’t say whether contamination was found. If you notice signs of infection where you injected, get medical care right away.
How do you report a problem with a compounded GLP-1 to FDA?
Use FDA’s MedWatch program, online at fda.gov/medwatch or by phone at 1-800-FDA-1088. FDA asks patients to report adverse events or quality problems with any medicine, like a reaction or a vial that arrived warm. It calls reporting online the quickest and most direct route.
Important safety information
Compounded tirzepatide and semaglutide are not FDA-approved, and the FDA hasn’t reviewed them for safety, effectiveness or quality. A provider prescribes them only when they offer a significant difference for you compared with an FDA-approved product. Both medicines may cause thyroid tumors, including cancer: don’t use either if you or a family member has had medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
Read the full safety information
In studies with rodents, both medicines caused thyroid tumors; it isn’t known whether they cause them in people. Tell your provider if you notice a lump or swelling in your neck, hoarseness, trouble swallowing or shortness of breath. Serious side effects can include inflammation of the pancreas (pancreatitis), gallbladder problems, low blood sugar (especially with insulin or sulfonylureas), kidney problems from dehydration, severe stomach problems, serious allergic reactions, vision changes in people with type 2 diabetes, and a faster heart rate. Tell your care team before any surgery or procedure that uses anesthesia or deep sedation. Don’t combine either medicine with other
Tirzepatide can make birth control pills less effective: switch to a non-oral method, or add a barrier method such as condoms, for 4 weeks after you start and for 4 weeks after each dose increase. Both medicines may harm an unborn baby. Semaglutide should be stopped at least 2 months before a planned pregnancy. Tell your provider right away if you’re pregnant, planning to be, or breastfeeding.
This is a summary, not the complete safety information. Read the full Prescribing Information for FDA-approved tirzepatide (Zepbound) and semaglutide (Wegovy), and talk with your provider. You can report side effects to the FDA at
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Who wrote and medically reviewed this page?
Leads the NexLife Medical Team, which writes and medically reviews NexLife’s guides, including this one.
FDA’s recall records checked November 1, 2026.
- How we checked. We read FDA’s recall records on November 1, 2026: openFDA’s drug enforcement data (last updated October 21, 2026) for Apothecary Pharma, Carolina Infusion, Houston Rx and Apollo Care. FDA’s Enforcement Report of October 28 wasn’t in that data yet. The same day, we read FDA’s pages on drug recalls, compounded
GLP-1s and MedWatch. News reports are cited for what they reported, and company statements are labeled as the companies’ own. NexLife publishes this guide. NexLife’s providers prescribe compounded tirzepatide and semaglutide, so we checked our own partner pharmacies against the same records. - Every fact, sourced. Each price and rule links to the page it comes from.
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Compounded medications aren’t FDA-approved. A provider prescribes one only when it offers a significant difference for you.
Sources
- FDA (openFDA): drug recall records for tirzepatide, July to October 2026 (Apothecary Pharma, Carolina Infusion, Houston Rx). Data updated October 21, 2026; read November 1, 2026.
- FDA (openFDA): drug recall records for semaglutide, July to October 2026 (Carolina Infusion, Apollo Care). Data updated October 21, 2026; read November 1, 2026.
- FDA (openFDA): recall event 99505, Apollo Care, every lot. Read November 1, 2026.
- FDA: Understanding Drug Recalls, what to know and what to do (Class II, and what to do if your drug is recalled). Read November 1, 2026.
- FDA: Concerns with unapproved
GLP-1 drugs used for weight loss (dated October 1, 2026). Read November 1, 2026. - FDA: MedWatch, safety information and adverse event reporting. Read November 1, 2026.
- FDA 101: how to use the Consumer Complaint System and MedWatch (reporting online and by phone). Read November 1, 2026.
- FOX 13 Tampa Bay (FOX Local, with FOX Business): the Apothecary Pharma recall and what it told readers to do (October 21, 2026). Read November 1, 2026.
- NewsNation (as published by KRQE): the Apothecary Pharma recall, FDA’s instructions and reported illnesses (October 23, 2026). Read October 31, 2026.
- USA Today: the Apothecary Pharma tirzepatide recall, its lots and NewLife Rx’s notice (October 19, 2026, updated October 20). Read October 24, 2026.
- MedlinePlus (U.S. National Library of Medicine): cellulitis, its symptoms and when to get care (reviewed April 1, 2025). Read November 1, 2026.
- U.S. Food and Drug Administration. Enforcement Report Information and Definitions. Class I, II and III, and recalls a firm starts on its own. Read November 2, 2026.
- U.S. Food and Drug Administration. Enforcement Reports. The weekly report, which lists recalls once FDA classifies them. Read November 2, 2026.
- U.S. Food and Drug Administration. Compounding and the FDA: Questions and Answers. Compounded drugs aren’t FDA-approved. Read November 2, 2026.