Recall Enforment Report D-0488-2025

Drug Recall Enforcement Report Class I voluntary initiated by Amneal Pharmaceuticals, LLC, originally initiated on 06-02-2025 for the 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. The product was recalled due to microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.. The product was distributed nationwide and the recall is currently ongoing.

Field Name	Field Value
Event ID	96985 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0488-2025 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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 For Recall	Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	6396 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	06-18-2025
Recall Initiation Date	06-02-2025 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Amneal Pharmaceuticals, LLC
Code Info	Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	65162-271-05; 65162-271-10; 65162-271-50; 65162-271-11; 65162-272-01; 65162-272-24; 65162-272-10; 65162-272-25; 65162-272-50
Status	Ongoing

Recalled Products