FDA Recall D-0625-2025

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · La Vergne, TN

Class II Ongoing 254 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, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).

Lot / code: Bag: N02309A and N02309B, Exp Date: 03/31/2027; Inner blister: Lot # N02309, Exp Date: 03/31/2027

Quantity: N/A

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-0625-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide.
Recall initiated: 2025-09-02
Classified by FDA Center: 2025-09-10
FDA published: 2025-09-17
Recalling firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Firm location: La Vergne, TN

Drug identification

Brand name(s): SULFAMETHOXAZOLE AND TRIMETHOPRIM
Generic name(s): SULFAMETHOXAZOLE AND TRIMETHOPRIM
Manufacturer(s): Cardinal Health 107, LLC, Major Pharmaceuticals
NDC(s): 55154-7895, 0904-2725
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.

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