The Recall Desk
ModerateFDA (Drugs)·D-0654-2025·Announced 2025-09-24

Prescription Antibiotic Tablets Recalled for Packaging Material Contamination

Northwind Pharmaceuticals recalls Sulfamethoxazole and Trimethoprim tablets due to microorganism found in packaging material. No microorganism detected on tablets; no illnesses reported.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for contamination detected in packaging material only, not in the actual drug product. The source explicitly states no microorganism was found on the tablets themselves, and no illnesses or injuries have been reported, supporting a precautionary moderate-risk classification.

Plain-English summary

Northwind Pharmaceuticals LLC is recalling specific lots of Sulfamethoxazole and Trimethoprim (Double Strength) 800mg/160mg tablets. The recall was initiated due to the discovery of a microorganism in a polyester coil component used in product packaging during manufacturing by Amneal Pharmaceuticals LLC.

Testing by the manufacturer determined that the microorganism was detected only in the packaging material. No microorganism was detected on any of the tablets themselves. The affected lots are distributed nationwide in multiple package sizes (6-count, 10-count, 14-count, and 20-count bottles).

No illnesses or injuries have been reported related to this recall. Patients currently taking this medication should consult their healthcare provider or pharmacist before making any changes.

The recalled product

Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
Brand
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Manufacturer
Northwind Pharmaceuticals LLC
Category
Drug — Prescription Antibiotic
Hazard
  • contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • 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.

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · SULFAMETHOXAZOLE AND TRIMETHOPRIM

Same category