Why it was 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.
Product description
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61
Lot numbers, UPCs & expiration codes
Lot # N02309, Exp 03/31/2027
Where it was sold
USA Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0624-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 2, 2025
- FDA report date
- Sep 17, 2025
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Original FDA data
Every field from FDA enforcement report D-0624-2025, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 97523
- Address
- 341 Mason Rd
- Code information
- Lot # N02309, Exp 03/31/2027
- Postal code
- 37086-3606
- Report date
- Sep 17, 2025
- Product type
- Drugs
- Recall number
- D-0624-2025
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61
- Distribution pattern
- USA Nationwide.
- Recall initiation date
- Sep 2, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 10, 2025