FDA Recall D-0654-2025

Northwind Pharmaceuticals LLC · Indianapolis, IN

Class II Ongoing 267 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.

Lot / code: 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.

Quantity: a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles

Reason for recall

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.

Recall record

Recall number: D-0654-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2025-08-20
Classified by FDA Center: 2025-09-17
FDA published: 2025-09-24
Recalling firm: Northwind Pharmaceuticals LLC
Firm location: Indianapolis, IN

Drug identification

Brand name(s): SULFAMETHOXAZOLE AND TRIMETHOPRIM
Generic name(s): SULFAMETHOXAZOLE AND TRIMETHOPRIM
Manufacturer(s): Northwind Health Company, LLC
NDC(s): 51655-307
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls