Sulfamethoxazole and Trimethoprim Recall: Major Pharmaceuticals
Announced 2025-10-15 · FDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories is recalling Lot N02309 of sulfamethoxazole and trimethoprim, USP 800 mg/160 mg, Double Strength, 100 Tablets per carton, Rx Only, distributed nationwide in the USA. The recall is due to the presence of a foreign substance—a specific lot of auxiliary polyester coil used in product packaging by Amneal Pharmaceuticals—that was detected with presence of a micro-organism; no micro-organism was detected on any tablets. The affected lot has an expiration date of 03/31/2027.
| Brand | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories |
|---|---|
| Product | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61 |
| Reason | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. |
| Severity | moderate |
| Units affected | 1394 |
| Distribution | USA Nationwide. |
| Agency | FDA |
| Recall / campaign no. | Lot # N02309, Exp 03/31/2027 |
WHAT YOU SHOULD DO
- Do not use recalled product from Lot N02309.
- Check your packaging for Lot N02309 and Exp 03/31/2027.
- Contact your pharmacy or the manufacturer for instructions on return or replacement.
- If you have used the product and have concerns, contact your healthcare provider.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.