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 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 numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide within the United States
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-0654-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 20, 2025
- FDA report date
- Sep 24, 2025
- Quantity
- a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Northwind Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-0654-2025, exactly as published.
Show all FDA fields
- City
- Indianapolis
- State
- IN
- Status
- Ongoing
- Country
- United States
- Event ID
- 97544
- Address
- 4838 Fletcher Ave Ste 1000
- Code information
- 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.
- Postal code
- 46203-1642
- Report date
- Sep 24, 2025
- Product type
- Drugs
- Recall number
- D-0654-2025
- Classification
- Class II
- Recalling firm
- Northwind Pharmaceuticals LLC
- Product 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 20, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 17, 2025