Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blis...
FDA Recall #D-0625-2025 — Class II — September 2, 2025
Product Description
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).
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.
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — La Vergne, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
USA Nationwide.
Code Information
Bag: N02309A and N02309B, Exp Date: 03/31/2027; Inner blister: Lot # N02309, Exp Date: 03/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated