Sulfamethoxazole and Trimethoprim recall
FDA recall D-0624-2025 · initiated Sep 2, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Sulfamethoxazole and Trimethoprim in Sep 2025 — an FDA Class II recall (D-0624-2025) because Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) 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 by manufacturer (Amneal Pharmaceuticals LLC) 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: N/A
Details
- Product
- Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61
- Recalling company
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide.
- Initiated
- Sep 2, 2025
- FDA report date
- Sep 17, 2025
Frequently asked
- Was Sulfamethoxazole and Trimethoprim recalled?
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Sulfamethoxazole and Trimethoprim in Sep 2025 — an FDA Class II recall (D-0624-2025) because Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) 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 recalled?
- Per the FDA enforcement record, the reason for recall D-0624-2025 was: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Is a recalled Sulfamethoxazole and Trimethoprim 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 are affected?
- Distributed: USA Nationwide.. The recall covers these lots — Lot # N02309, Exp 03/31/2027. 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-0624-2025.