June 4, 2025 — Amneal has recalled an antibiotic that may have moldy black spots on the pill.
No illnesses were reported, but Amneal issued the recall after receiving a complaint of black spots on the surface of the tablet. The pills may be contaminated with mold, such as Aspergillus.
“The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections.”
The recalled antibiotic is indicated to treat certain types of urinary tract infections, ear infections, bronchitis, enteritis, and traveler’s diarrhea.
The recall involves 3 lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80, packaged in 100-tablet and 500-tablet bottles.
These antibiotics were distributed nationwide between December 4, 2024 and May 15, 2025.
The recall only involves the 400 mg/80 mg strength, and only the lots listed in the table below. Lot numbers can be found on the bottle.
| Lot Number | NDC Number | Expiration date | Date of First Distribution | Bottle Pack Size |
|---|---|---|---|---|
| AM241019 | 65162-271-10 | 06/2027 | 12/4/2024 | 100 count |
| AM241019A | 65162-271-50 | 06/2027 | 12/4/2024 | 500 count |
| AM241020 | 65162-271-10 | 06/2027 | 12/4/2024 | 100 count |
Amneal Pharmaceuticals said there were “no reports of adverse events, illnesses or injuries related to this recall,” as of June 2, 2025.
Customers should contact Amneal directly for assistance with the return of any recalled products and reimbursement information.
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