Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sulfamethoxazole and Trimethoprim Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Due to Presence of a Foreign Substance: A specific lot...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories directly.
Affected Products
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).
Quantity: N/A
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report