Sulfamethoxazole and Trimethoprim Tablets recall
FDA recall D-0654-2025 · initiated Aug 20, 2025
Northwind Pharmaceuticals LLC recalled Sulfamethoxazole and Trimethoprim Tablets in Aug 2025 — an FDA Class II recall (D-0654-2025) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
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.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles
Details
- Product
- 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.
- Recalling company
- Northwind Pharmaceuticals LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Aug 20, 2025
- FDA report date
- Sep 24, 2025
Frequently asked
- Was Sulfamethoxazole and Trimethoprim Tablets recalled?
- Northwind Pharmaceuticals LLC recalled Sulfamethoxazole and Trimethoprim Tablets in Aug 2025 — an FDA Class II recall (D-0654-2025) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Sulfamethoxazole and Trimethoprim Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0654-2025 was: 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.
- Is a recalled Sulfamethoxazole and Trimethoprim Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sulfamethoxazole and Trimethoprim Tablets are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — 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. …. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0654-2025.