FDA's October Enforcement Reports List Sterility Recalls of Injectable Tirzepatide, Semaglutide and Sermorelin
The short version
- The FDA's Enforcement Reports of 14 and 21 October 2026 list recalls of injectable tirzepatide, semaglutide and sermorelin from three firms, all Class II and all for lack of assurance of sterility or lack of process control.
- A fourth firm, Centric Compounding of Texas, is listed with a glutathione blend recalled over out-of-specification bacterial endotoxin results. The FDA had not classified it when the report was published.
- The largest entry is Carolina Infusion of South Carolina: 16 records, nine of them tirzepatide, semaglutide or sermorelin. Its reason cites "formulation using bacteriostic water" and "processing equipment".
- The records do not say anyone was harmed, and none involves BPC-157 or the other research peptides in the July advisory vote.
- They bear on the question of whether a prescription and pharmacy route is a quality guarantee on its own.
Two weekly FDA Enforcement Reports in October list recalls of prescription peptide injectables. Between them, the reports of 14 and 21 October 2026 carry 12 Class II recalls of tirzepatide, semaglutide and sermorelin from three firms, plus one glutathione blend not yet classified. None is a research-use-only product, and none involves BPC-157, TB-500 or the other peptides voted on in July. This is what the FDA record says, as of 27 October 2026, and what it leaves out.
The recalls
| Firm | Peptide products listed | Reason, as the FDA record words it | Dates |
|---|---|---|---|
| Apothecary Pharma LLC, Cary, North Carolina | Tirzepatide injection 18 mg/mL, 4 mL multi-dose vial: 22 vials (one NAD+ vial in the same event) | "Lack of Assurance of Sterility" | Recall started 24 September; classified 8 October; report of 14 October |
| Carolina Infusion, LLC, Ridgeland, South Carolina | Nine records: five tirzepatide (alone or with cyanocobalamin), three semaglutide (alone or with cyanocobalamin), one sermorelin acetate. Patient-specific syringes. Seven other records are non-peptide injectable mixes. | "Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product." (spelling as in the record) | Recall started 10 September; classified 8 October; report of 14 October |
| Houston Rx LLC, Houston, Texas | Tirzepatide/niacinamide, 64 vials; sermorelin 1 mg/mL, 7 vials | "Lack of assurance of sterility." (tirzepatide/niacinamide); "Lack of process control" (sermorelin) | Recall started 25 September; classified 13 October; report of 21 October |
| Centric Compounding LLC, Tomball, Texas | "Tri-Immune Boost" glutathione, ascorbic acid and zinc, 30 mL vial, one lot | "Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin." | Recall started 27 July; listed in report of 14 October; "Not Yet Classified" |
Source: FDA Enforcement Report data for drugs, served by openFDA (api.fda.gov, data last updated 21 October 2026), queried 27 October 2026. All four recalls are listed as voluntary and firm-initiated, with nationwide distribution and status "Ongoing".
What "Class II" means
The FDA defines a Class II recall as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." It is the middle of three classes. Class I is the most serious.
What the record does not say
- No harm is reported. The Enforcement Report entries carry no illness or injury count. We are not saying no one was hurt, only that the record does not say.
- "Lack of assurance" is not a contamination finding. For Apothecary, Carolina Infusion and Houston Rx the stated reason is about assurance of sterility or process control, not a positive test. Centric Compounding is the exception: its entry cites out-of-specification bacterial endotoxin results.
- No cause beyond the reason line. Carolina Infusion's entry points at the formulation with bacteriostatic water and at processing equipment. The records say nothing further.
- Not the research peptides in the news. The tirzepatide, semaglutide and sermorelin here are different from BPC-157, KPV, TB-500 and the others the FDA's advisory committee voted on in July (every tally).
Why it matters now
Carolina Infusion's records describe its products as compounded and dispensed in patient-specific syringes. The other records do not say how the products were made, but each is labelled Rx only, so they travel through prescribers and pharmacies, the channel Health Secretary Robert F. Kennedy Jr. has pointed to as the route to a regulated peptide market. The FDA's own description of compounding is that "compounded drugs are not FDA approved, which means the agency does not review their safety, effectiveness or quality before they are marketed." Earlier this year the FDA reported at least 30 patients with adverse events after compounded intravenous glutathione made from a supplement-grade ingredient. The October records add sterility recalls of prescription injectables to that list. They do not show that the prescription route is worse than any other. They do show it is not a guarantee of quality on its own, which is the question in our report on the regulated peptide marketplace and in the White House review of the interim access policy.
For anyone drawing up injectables at home, the reasons cited here are about sterility: the diluent, the equipment and the process. Our guides on storing and handling peptides cover the handling you control.
How we searched
We pulled all 72 drug records with report dates from 23 September to 27 October 2026 and searched the product names for peptide and peptide-hormone terms (tirzepatide, semaglutide, sermorelin, exenatide, glutathione, goserelin, insulin, oxytocin and similar). Two other peptide entries in that window are outside this story: an exenatide pen recalled by Amneal for a delivery-system defect, and a Zoladex (goserelin) implant recalled by TerSera for temperature abuse. The FDA posts a new report weekly, so the entries can change as the FDA classifies them.
What to watch
- Whether the FDA classifies the Centric Compounding recall, and in which class.
- The reports of 28 October and after, for further peptide entries.
- The FDA's warning letters page, for any letter to these firms.
We will update this piece when the record changes. Every regulator action on peptides we have verified is in the enforcement tracker.
Questions readers ask
Which peptide products were recalled in October 2026?
The FDA's Enforcement Reports of 14 and 21 October 2026 list Class II recalls of tirzepatide from Apothecary Pharma, Carolina Infusion and Houston Rx, semaglutide from Carolina Infusion, and sermorelin from Carolina Infusion and Houston Rx. A glutathione blend from Centric Compounding is also listed, not yet classified.
Why were they recalled?
For lack of assurance of sterility, with one sermorelin entry citing lack of process control. Carolina Infusion's entry points to formulation using bacteriostatic water and processing equipment. The glutathione blend was recalled over out-of-specification bacterial endotoxin results.
Did anyone get sick?
The Enforcement Report entries do not say. They carry no illness or injury count, and a lack-of-assurance reason is not a finding that a vial was contaminated.
Are BPC-157 or other research peptides recalled?
No. None of the October entries involves BPC-157, KPV, TB-500, MOTS-c, emideltide, semax or epitalon.
What does a Class II recall mean?
The FDA defines it as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Sources
- FDA Enforcement Report data for drugs, via openFDA: Apothecary Pharma LLC, recalls D-0036-2027 and D-0037-2027 (event 99952), report of 14 October 2026; queried 27 October 2026
- FDA Enforcement Report data for drugs, via openFDA: Carolina Infusion, LLC, recalls D-0017-2027 to D-0032-2027 (event 99867), report of 14 October 2026; queried 27 October 2026
- FDA Enforcement Report data for drugs, via openFDA: Houston Rx LLC, recalls D-0040-2027 and D-0041-2027 (event 99990), report of 21 October 2026; queried 27 October 2026
- FDA Enforcement Report data for drugs, via openFDA: Centric Compounding LLC (event 99860, not yet classified), report of 14 October 2026; queried 27 October 2026
- FDA: Recalls Background and Definitions, content current as of 20 March 2026; read 27 October 2026
- FDA: Human drug compounding, content current as of 15 June 2026
- FDA: FDA reminds compounders not to use dietary supplement grade glutathione for injectables, 27 August 2026