Amneal Pharmaceuticals, LLC Recalls

4 recalls on record in the United States

drugs: 4
drugs Class II
2026-04-08

Amneal Pharmaceuticals, LLC recalls traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottle

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).

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drugs Class I
2026-04-08

Amneal Pharmaceuticals, LLC recalls Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL

Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.

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drugs Class III
2026-06-17

Amneal Pharmaceuticals, LLC recalls Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx on

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

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drugs Class II
2026-10-07

Amneal Pharmaceuticals, LLC recalls Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only

Defective Container; packets were found to be either empty or partially full.

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