FDA drug recalls · openFDA

Is SULFAMETHOXAZOLE AND TRIMETHOPRIM recalled?

The FDA has recorded 5 recalls of SULFAMETHOXAZOLE AND TRIMETHOPRIM (2025) , recalled under brand like SULFAMETHOXAZOLE AND TRIMETHOPRIM. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of SULFAMETHOXAZOLE AND TRIMETHOPRIM ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer ( 3

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected wit 1

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) Class I ongoing

Amneal Pharmaceuticals, LLC 2025-06-02 lots: Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, N Class II ongoing

Amneal Pharmaceuticals, LLC 2025-08-18 lots: Lot a) AM240173, Exp Date 01/31/2027, AM240680, Exp Date 05/31/2027, AM 240921, Exp Date 06/30/2027, AM241191, Exp Date 08/31/2027. Lot b) AM240176, AM240177, Exp Date 01/31/2027, AM240301, AM240300, Exp Date 02/28/2027, AM240676, AM240677, Exp Date 04/30/2027, AM240678, AM240679, Exp Date 05/30/2027. AM240922, AM240923, AM240924, AM240925, Exp Date 6/30/27, AM241086, Exp Date 7/31/27, AM241087, AM241088, Exp Date 8/31/27.

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag Class II ongoing

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-09-02 lots: Bag: N02309A and N02309B, Exp Date: 03/31/2027; Inner blister: Lot # N02309, Exp Date: 03/31/2027

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per Class II ongoing

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2025-09-02 lots: Lot # N02309, Exp 03/31/2027

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-3 Class II ongoing

Northwind Pharmaceuticals LLC 2025-08-20 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. Date 04/30/2027; F118062508, Exp. Date 08/31/2027.

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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