Amneal Pharmaceuticals, LLC
12 federal recalls on file, showing the 4 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Amneal Pharmaceuticals, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-06-17FDA-DrugClass IIIAmneal Primidone tablets recalled for cross-contamination risk
Amneal Pharmaceuticals is recalling Primidone 50 mg tablets (NDC 53746-544-01, lot AM251676) due to potential cross-contamination with Acemetacin during manufacturing at the API supplier. The contamination could affect the safety or effectiveness of the medication.
- 2026-04-08FDA-DrugClass IStop using Amneal Magnesium Sulfate IV bags
Some cartons of Amneal Magnesium Sulfate IV bags were mislabeled and contained Tranexamic Acid (a different medication) instead. This mix-up affects lot AH250162 with an expiration date of 8/31/2027. The error was discovered before the product reached patients.
- 2026-04-08FDA-DrugClass IIStop using Amneal tramadol tablets
Amneal Pharmaceuticals is recalling specific lots of tramadol 50 mg tablets because they contain higher-than-allowed levels of a chemical impurity called N-nitroso-desmethyl-tramadol (NDSRI). The impurity was discovered during stability testing of tablets nearing the end of their shelf life. No injuries have been reported.
- 2026-03-24FDA-PRStop using Amneal Magnesium Sulfate IV bags
One lot of Amneal Magnesium Sulfate in Water for Injection IV bags was found to contain the wrong medication—Tranexamic Acid—inside the packaging. This mix-up affects hospitals that received the product between late December 2025 and late February 2026. No patients have been harmed so far.
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