Safety Alert: Class II: 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.
healthClass IIRecalled on Sep 17, 2025
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only
🔢 N/A
Sold At: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories(USA Nationwide.)
Recall #: FDA-DRUG-D-0624-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Lot # N02309, Exp 03/31/2027
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Summary
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.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.