RecallRadar

FDA Drug recall D-0488-2025

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bot…

On 2025-06-18 the FDA classified a Class I recall of Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bot… by Amneal Pharmaceuticals, citing microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0488-2025
ClassificationClass I
Statusongoing
Initiated2025-06-02
Published2025-06-18
Last updated2026-09-13 11:52 UTC
CompanyAmneal Pharmaceuticals
DistributionUS

Product

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

Reason

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

Identifiers

ndc65162-271-05
ndc65162-271-10
ndc65162-271-50
ndc65162-271-11
ndc65162-272-01
ndc65162-272-24
ndc65162-272-10
ndc65162-272-25
ndc65162-272-50
code_infoLot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0488-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.