Amneal Pharmaceuticals, LLC recalls
16 recalls in our records from 2017 to 2026: 16 FDA drugs.
Recalls with full detail pages
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Amneal Pharmaceuticals, LLC drug recall: Magnesium Sulfate in Water for Injection
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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Amneal Pharmaceuticals, LLC drug recall: Sulfamethoxazole and Trimethoprim Tablets
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
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Amneal Pharmaceuticals, LLC drug recall: Ropivacaine Hydrochloride Injection
Presence of Particulate Matter
Earlier and other recalls
These link to the official agency notice.
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Amneal Pharmaceuticals, LLC drug recall: Estradiol Gel Official notice ↗
Defective Container; packets were found to be either empty or partially full.
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Amneal Pharmaceuticals, LLC drug recall: Primidone Tablets Official notice ↗
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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Amneal Pharmaceuticals, LLC drug recall: traMADol Hydrochloride Tablets Official notice ↗
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long…
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Amneal Pharmaceuticals, LLC drug recall: Sulfamethoxazole and Trimethoprim Tablets Official notice ↗
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…
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Amneal Pharmaceuticals, LLC drug recall: Methotrexate Tablets Official notice ↗
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
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Amneal Pharmaceuticals, Inc. drug recall: Ranitidine Tablets Official notice ↗
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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Amneal Pharmaceuticals, Inc. drug recall: Isotretinoin Capsules Official notice ↗
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
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Amneal Pharmaceuticals, Inc. drug recall: Benazepril HCl Tablets Official notice ↗
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
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Amneal Pharmaceuticals, Inc. drug recall: Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count Official notice ↗
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
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Amneal Pharmaceuticals, Inc. drug recall: Esterified Estrogens & Methyltestosterone Tablets Official notice ↗
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
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Amneal Pharmaceuticals drug recall: Fosphenytoin Sodium Injection Official notice ↗
Presence of particulate matter
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Amneal Pharmaceuticals LLC drug recall: Fosphenytoin Sodium Injection Official notice ↗
Presence of Particulate Matter
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Amneal Pharmaceuticals LLC drug recall: Rabeprazole Sodium Delayed Release Tablets Official notice ↗
Failed Dissolution Specifications
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.