RecallCheckr

Amneal Pharmaceuticals, LLC recalls

6 recalls on record · 2 rated Critical · FDA

Every recall we have on record for Amneal Pharmaceuticals, LLC, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.

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Health Serious

traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by:…

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).

Amneal Pharmaceuticals, LLC Apr 8, 2026
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Health Critical

Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in…

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.

Amneal Pharmaceuticals, LLC Apr 8, 2026
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Health Serious

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only,…

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.

Amneal Pharmaceuticals, LLC Sep 10, 2025
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Health Serious

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only,…

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.

Amneal Pharmaceuticals, LLC Sep 10, 2025
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Health Serious

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only,…

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.

Amneal Pharmaceuticals, LLC Sep 10, 2025
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Health Critical

Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured…

Presence of Particulate Matter

Amneal Pharmaceuticals, LLC May 14, 2025
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