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Compounded GLP-1 recalls, October 2026: is your vial on the list?
Medically reviewed by the NexLife clinical team, led 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 Class II means, in FDA’s own words
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Key takeaways
- Three recalls, all Class II. Apothecary Pharma, Carolina Infusion and Houston Rx recalled compounded tirzepatide and semaglutide injections. FDA classified them from October 8 to 13, 2026.
- FDA’s reason for each: lack of assurance of sterility. Some companies have told customers it was a documentation issue. That’s their explanation, not FDA’s.
- The companies started them. None was requested by FDA, and they were distributed across the U.S., per FDA’s records.
- Check your label first. If the pharmacy and lot number match, or you aren’t sure, talk with your prescriber or pharmacist before you use it.
- Get care for signs of infection where you injected: redness that spreads, warmth, swelling or pain, or a fever with chills. Then report it to FDA’s MedWatch.
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 14, 2026) and, for Houston Rx, FDA’s Enforcement Report site, checked October 24, 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, and the recalls reached the national news from October 19 to 23.
Updated: last checked October 24, 2026, against FDA’s recall records.
What to do
What to do if your 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 .
FDA’s rules for any compounded GLP-1 vial
- Throw away a multi-dose vial within 28 days after you first use it, even if medicine is left, and even if the compounder’s instructions say it lasts longer.
- Use a new, sterile needle and syringe for every dose.
- Don’t use an injectable
GLP-1 that arrives warm, or without enough refrigeration.
From FDA’s page on unapproved
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.”
FDA adds: “Talk to your doctor or pharmacist if you have questions or concerns about your medicine.”
No public instructions for the Apothecary vials, as of October 23. USA Today reported that neither FDA nor Apothecary had issued a public statement on what to do with affected vials. On October 23, The Hill reported that FDA had not released official instructions. That’s why our steps say to check your lot and ask before you use it.
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 status
Are compounded GLP-1s FDA-approved?
No. Compounded
FDA explains what that means:
“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 this affect NexLife?
No. Neither of NexLife’s two partner pharmacies is named in FDA’s records for these recalls.
Our partner pharmacies. 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 the Apothecary Pharma, Carolina Infusion, Houston Rx or Apollo Care recalls (checked October 24, 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.
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Compounded GLP-1 recalls: your questions
Which compounded GLP-1s were recalled in October 2026?
FDA classified three recalls of compounded
How do I know if my compounded tirzepatide is recalled?
Check your label for the pharmacy name and the lot number, and compare them with FDA’s list. Apothecary Pharma’s recalled 18 mg/mL vials carry lots
Can I keep using a vial from a Class II recall?
If your lot matches, or you aren’t sure, don’t use it until you’ve talked with your prescriber or pharmacist. FDA’s general rule for Class II recalls is that patients “can continue using the medicine unless otherwise directed by the recalling company or FDA.” But these recalls are about sterility, and FDA hadn’t released official instructions for the Apothecary vials as of October 23, The Hill reported.
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.”
Did FDA order these recalls?
No. FDA’s records code all three “Voluntary: Firm initiated,” which means the companies started them. FDA then classified each one as Class II, and its records list distribution across the U.S.
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. Then report the problem to FDA’s 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
How do I report a problem with a compounded GLP-1?
Report it to FDA’s MedWatch program, online at fda.gov/medwatch or by phone at
Was Apollo Care’s semaglutide recalled too?
Yes, in an earlier, separate recall. Apollo Care, LLC, of Columbia, MO, recalled semaglutide vials, some with glycine, for “Presence of Particulate Matter.” It began July 29 and was classified Class II on August 7, 2026.
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 checked this page
Leads the NexLife clinical team, which medically reviewed this page on October 24, 2026.
FDA’s recall records checked October 24, 2026.
- How we checked. We read FDA’s recall records on October 24, 2026: openFDA’s drug enforcement data (last updated October 14, 2026) for Apothecary Pharma, Carolina Infusion and Apollo Care, and FDA’s Enforcement Report site for Houston Rx, which wasn’t in openFDA’s 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.
- How we make money. NexLife is a telehealth and care-coordination platform. We earn revenue when people join NexLife.
- Corrections, fast. See something wrong or out of date? Email care@nexlife.us and we’ll fix it.
Sources
- FDA (openFDA): drug recall records for tirzepatide, July to October 2026 (Apothecary Pharma, Carolina Infusion). Data updated October 14, 2026; read October 24, 2026.
- FDA (openFDA): drug recall records for semaglutide, July to October 2026 (Carolina Infusion, Apollo Care). Read October 24, 2026.
- FDA (openFDA): recall event 99505, Apollo Care, every lot. Read October 24, 2026.
- FDA Enforcement Report: recall event 99990, Houston Rx. Read October 24, 2026.
- FDA: Understanding Drug Recalls, what to know and what to do. Read October 24, 2026.
- FDA: Concerns with unapproved
GLP-1 drugs used for weight loss (dated October 1, 2026). Read October 24, 2026. - FDA: MedWatch, safety information and adverse event reporting. Read October 24, 2026.
- FDA 101: how to use the Consumer Complaint System and MedWatch (reporting by phone). Read October 24, 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.
- The Hill (NewsNation): the Apothecary Pharma recall and FDA’s instructions (October 23, 2026). Read October 24, 2026.
- MedlinePlus (U.S. National Library of Medicine): cellulitis, its symptoms and when to get care (reviewed April 1, 2025). Read October 24, 2026.