Class III · Low risk Ongoing
Primidone Tablets
Reason Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Sulfamethoxazole and Trimethoprim Tablets
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
What was recalled
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.
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0488-2025
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Sage recalls
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Class III · Low risk Ongoing
Busulfan Injection
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason 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.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason 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.
Class II · Moderate risk Ongoing
chlorproMAZINE Hydrochloride Tablets
Reason 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.
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