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 24, 2025
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87)
🔢 a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles
Sold At: Northwind Pharmaceuticals LLC(Nationwide within the United States)
Recall #: FDA-DRUG-D-0654-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Lot #: a) F118062503, Exp Date 05/31/2027, F118062507, Exp Date. 07/31/2027. b) F118062504, F118062505, Exp. Date 05/31/2027; F118062509, Exp. Date. 08/31/2027; F118062512, Exp. Date 04/30/2027. c) F118062506, Exp. Date 06/30/2027. d) F118062423, Exp. Date 01/31/2027; F118062501, Exp. Date 06/30/2027; F118062502, Exp. Date 04/30/2027; F118062508, Exp. Date 08/31/2027.
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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 Northwind Pharmaceuticals LLC for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.