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

Double strength antibiotic bottles recalled over micro-organism on packaging coil

Sulfamethoxazole and Trimethoprim Tablets, USP 800 mg/160 mg double strength, in 6, 10, 14 and 20-count bottles are recalled because a micro-organism was found on a lot of packaging coil.

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: Rubric level 2 covers precautionary recalls; the contamination was found on a packaging component and the notice states no micro-organism was detected on any tablets.

Plain-English summary

Sulfamethoxazole and Trimethoprim Tablets, USP 800 mg/160 mg, double strength and available on prescription only, are being recalled in 6-count bottles (NDC 51655-307-87), 10-count bottles (NDC 51655-307-53), 14-count bottles (NDC 51655-307-84) and 20-count bottles (NDC 51655-307-20). The recall covers 96, 627, 428 and 1,144 bottles of each presentation respectively, with affected lots including F118062503, F118062504, F118062505 and F118062507, distributed nationwide.

The recall was issued for the presence of a foreign substance: a specific lot of auxiliary polyester coil used in product packaging by the manufacturer, Amneal Pharmaceuticals LLC, was found to contain a micro-organism. The notice states that no micro-organism was detected on any tablets. The FDA classified the action as Class II.

Patients should check the lot number on their bottle against the recall and should speak to their pharmacist about a replacement supply before stopping a prescribed antibiotic.

The recalled product

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

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.

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