CLASS II ONGOING Drug recall · Reported 10 Sep 2025 · FDA Enforcement Report

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalled

Amneal Pharmaceuticals is recalling Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, distributed nationwide in the US. The recall was initiated on 18 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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.

NDC65162-271, 65162-272

UPC0365168211102, 0365162272109

Quantity recalled60,072 100-count, 73,054 500-count bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0615-2025
FDA event ID: 97438
Recalling firm: Amneal Pharmaceuticals, Bridgewater, NJ
Brand: Sulfamethoxazole And Trimethoprim
Manufacturer: Amneal Pharmaceuticals LLC
Classification: Class II
Status: Ongoing
Recall initiated: 18 Aug 2025
FDA classified: 4 Sep 2025
Reported: 10 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Antibiotics

Timeline

18 Aug 2025	Recall initiated by company
4 Sep 2025	Classified by FDA	+17 days
10 Sep 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

Where it was distributed

Distributed Nationwide in the USA

Nationwide

Questions about this recall

Is Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength recalled?

Yes. Amneal Pharmaceuticals recalled Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength on 18 Aug 2025. The recall is Class II and its status is Ongoing. Recall number D-0615-2025.

Why was it recalled?

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Which lots are affected?

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.

Where was it sold?

Distributed Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Sulfamethoxazole recalls

All 10

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim	Northwind Pharmaceuticals	Packaging Defects	Nationwide
17 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	The Harvard Drug Group	Packaging Defects	Nationwide
17 Sep 2025Drug	CLASS II	Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim	The Harvard Drug Group	Packaging Defects	Nationwide
18 Jun 2025Drug	CLASS I	Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg recalledSulfamethoxazole And Trimethoprim	Amneal Pharmaceuticals	Sterility	Nationwide
15 Jun 2022Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide