Sulfamethoxazole and Trimethoprim Tablets recall
FDA recall D-0615-2025 · initiated Aug 18, 2025
Amneal Pharmaceuticals, LLC recalled Sulfamethoxazole and Trimethoprim Tablets in Aug 2025 — an FDA Class II recall (D-0615-2025) because 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.
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 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: 60,072 100-count, 73,054 500-count bottles
Details
- Product
- 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.
- Recalling company
- Amneal
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Aug 18, 2025
- FDA report date
- Sep 10, 2025
Frequently asked
- Was Sulfamethoxazole and Trimethoprim Tablets recalled?
- Amneal Pharmaceuticals, LLC recalled Sulfamethoxazole and Trimethoprim Tablets in Aug 2025 — an FDA Class II recall (D-0615-2025) because 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. 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-0615-2025 was: 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.
- 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: Distributed Nationwide in the USA. The recall covers these 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, AM24092…. 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-0615-2025.