# Two compounders recall GLP-1 injections over sterility

> Source: https://peptidewellnessusa.com/news/compounded-glp-1-sterility-recalls-october-2026/
> News · Safety · October 2026
> By PeptideWellness Editorial Team · Updated October 28, 2026 · 3 min read

The FDA's October 14 Enforcement Report lists 18 recalled compounded injections from two pharmacies, ten of them tirzepatide or semaglutide. Both firms had received FDA warning letters before. Here is what was recalled, what the recall class means, and what to check if you have a vial or syringe at home.

The FDA's weekly [Enforcement Report](https://www.accessdata.fda.gov/scripts/ires/index.cfm) for October 14, 2026 lists 18 recalls of compounded injectable drugs from two pharmacies: Apothecary Pharma LLC of Cary, North Carolina, and Carolina Infusion, LLC of Ridgeland, South Carolina. Ten of the 18 are tirzepatide or semaglutide. Every entry carries the same reason, "Lack of Assurance of Sterility," and every one is Class II.

Neither pharmacy appears in our [compounding pharmacy directory](https://peptidewellnessusa.com/professionals/compounding-pharmacies/), and none of the telehealth providers we review names either one as a dispensing pharmacy.

## What was recalled

**Apothecary Pharma LLC**, Cary, NC. Recall started September 24, 2026, distributed nationwide:

| Recall | Product | Quantity |
| --- | --- | --- |
| D-0036-2027 | Tirzepatide injection 18 mg/mL, 4 mL multi-dose vial | 22 vials |
| D-0037-2027 | NAD+ injection 200 mg/mL, 6 mL vial | 1 vial |

**Carolina Infusion, LLC**, Ridgeland, SC. Recall started September 10, 2026, distributed nationwide, all products dispensed as patient-specific syringes. For every GLP-1 product the recall gives two causes: a formulation that used bacteriostatic water, and the processing equipment. The GLP-1 products:

| Recall | Product | Quantity |
| --- | --- | --- |
| D-0017-2027 | Tirzepatide 26 mg/mL | 5.6 mL |
| D-0027-2027 | Tirzepatide/cyanocobalamin 26/2 mg/mL | 297 mL |
| D-0028-2027 | Tirzepatide/cyanocobalamin 64/2 mg/mL | 29.6 mL |
| D-0029-2027 | Tirzepatide/cyanocobalamin 76/2 mg/mL | 24.8 mL |
| D-0030-2027 | Tirzepatide/cyanocobalamin 85/2 mg/mL | 30.4 mL |
| D-0018-2027 | Semaglutide 3 mg/mL | 8 × 0.1 mL syringes |
| D-0019-2027 | Semaglutide/cyanocobalamin 3/2 mg/mL | 57.0 mL |
| D-0026-2027 | Semaglutide/cyanocobalamin 9/2 mg/mL | 82.9 mL |

The same Carolina Infusion recall also covers sermorelin acetate 1 mg/mL (D-0020-2027) and seven Tri-Mix and Quad-Mix erectile-dysfunction injections (D-0021 to D-0025 and D-0031, D-0032-2027).

## What "lack of assurance of sterility" and Class II mean

"Lack of assurance of sterility" means the pharmacy cannot show the product was made under conditions that keep it sterile. It is not the same as a finding that the product was contaminated, and neither recall entry reports a contaminated lot or an injury.

Class II is the middle of FDA's three recall classes. FDA [uses it](https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions) where the product may cause temporary or medically reversible health problems, or where the chance of serious harm is remote. Class I is reserved for products that could cause serious harm or death.

Both recalls were started by the firms themselves, and FDA lists both as ongoing.

## Both firms had FDA warning letters already

Apothecary Pharma is a registered 503B outsourcing facility. FDA inspected it May 12–15, 2025 and sent a [warning letter dated December 1, 2025](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apothecary-pharma-llc-717972-12012025), posted in March 2026. The letter found that its tirzepatide 10 mg/mL and semaglutide 2.5 mg/mL labels left out required ingredient information, that its adverse-event procedures were inadequate, and that its sterile practices fell short. The letter records that the firm stopped sterile production on the first day of the inspection and planned to restart it in August 2025.

Carolina Infusion operates as a 503A pharmacy. FDA inspected it from July 18 to August 12, 2022 and sent a [warning letter dated May 22, 2023](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/carolina-infusion-659408-05222023).

Apothecary Pharma's letter names tirzepatide and semaglutide, so it is in our [register of FDA warning letters to compounding pharmacies](https://peptidewellnessusa.com/learn/fda-warning-letters-compounding-pharmacies/). Carolina Infusion's 2023 letter predates January 2025, where the register starts. The register also includes the [warning letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026) FDA sent to [Empower Pharmacy](https://peptidewellnessusa.com/professionals/compounding-pharmacies/empower-pharmacy/) on September 18, 2026. That letter concerns copies of approved GLP-1 drugs with added niacinamide or B12, and insanitary conditions.

## Update, October 28: a third pharmacy

FDA's Enforcement Report for October 21, 2026 adds a third compounder. **Houston Rx LLC**, a 503A pharmacy in Houston, Texas, started a recall on September 25, 2026, distributed nationwide:

| Recall | Product | Lot, beyond-use date | Quantity | Reason |
| --- | --- | --- | --- | --- |
| D-0040-2027 | Tirzepatide/niacinamide 20/2 mg/mL, 2 mL vial | TZN-080326-20/2-2, Dec 1, 2026 | 64 vials | Lack of assurance of sterility |
| D-0041-2027 | Sermorelin 1 mg/mL, 10 mL vial | SER-081726-1-10, Oct 1, 2026 | 7 vials | Lack of process control |

Both are Class II, started by the firm, and listed as ongoing. The tirzepatide lot is dated to December 1, 2026, so vials from it may still be in use.

FDA's compounding-actions list shows no warning letter for Houston Rx. It does show a [Form 483](https://www.fda.gov/media/195122/download) issued August 28, 2026 after an inspection from August 20 to 28, with 14 observations, among them staff performing aseptic steps with exposed hair or skin and microbial contamination in the ISO 5 area. Houston Rx is not in our directory, and none of the providers we review names it as a dispensing pharmacy.

## If you have a compounded GLP-1 at home

- Look at the label. A compounded drug's label names the pharmacy that made it. If it says Apothecary Pharma, Carolina Infusion or Houston Rx, stop using it and contact the pharmacy and the prescriber who ordered it.
- Ask your telehealth provider which pharmacy fills your prescription if the label is gone or unclear. A provider that will not tell you is a reason to look elsewhere; our guide on [what to ask before a first order](https://peptidewellnessusa.com/learn/what-to-ask-before-first-order/) covers this.
- Redness, swelling, warmth or pus at an injection site, or a fever after an injection, are signs of infection. Get medical care, and mention the product and pharmacy.
- Report problems to FDA MedWatch at 1-800-FDA-1088 or through the [MedWatch online form](https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program).

## References

1. [FDA — Enforcement Report, report date October 14, 2026: Carolina Infusion, LLC, recalls D-0017-2027 to D-0032-2027, event 99867](https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99867); [Apothecary Pharma LLC, recalls D-0036-2027 and D-0037-2027, event 99952](https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99952).
2. [FDA — Enforcement Report.](https://www.accessdata.fda.gov/scripts/ires/index.cfm)
3. [FDA — Recalls Background and Definitions.](https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions)
4. [FDA — Warning Letter, Apothecary Pharma LLC, MARCS-CMS 717972, December 1, 2025.](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apothecary-pharma-llc-717972-12012025)
5. [FDA — Warning Letter, Carolina Infusion, MARCS-CMS 659408, May 22, 2023.](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/carolina-infusion-659408-05222023)
6. [FDA — Warning Letter, Empower Clinic Services, LLC dba Empower Pharmacy, MARCS-CMS 738238, September 18, 2026.](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026)
7. [FDA — Enforcement Report, report date October 21, 2026: Houston Rx LLC, recalls D-0040-2027 and D-0041-2027, event 99990.](https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99990)
8. [FDA — Form 483, Houston Rx LLC, Houston, TX, issued August 28, 2026.](https://www.fda.gov/media/195122/download)

> Editorial note: Informational only — not medical advice. Decisions about GLP-1 therapy, compounded or branded, should be made with a licensed healthcare provider familiar with your medical history. Last reviewed October 2026.