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Amneal Pharmaceuticals Recalls
24 recalls on record · May 10, 2017 to June 17, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 17, 2026DrugsFDA
Amneal Pharmaceuticals, LLC recalls Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral
Hazard: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
April 8, 2026DrugsFDA
Amneal Pharmaceuticals, LLC recalls Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags
Hazard: 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.
April 8, 2026DrugsFDA
Amneal Pharmaceuticals, LLC recalls traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Lt
Hazard: 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).
September 10, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pv
Hazard: 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.
September 10, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals P
Hazard: 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.
September 10, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt
Hazard: 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.
September 10, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pv
Hazard: 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.
September 10, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, N
Hazard: 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.
June 18, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b)
Hazard: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
May 14, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt.
Hazard: Presence of Particulate Matter
August 14, 2024DrugsFDA
Amneal Pharmaceuticals, LLC recalls Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ
Hazard: Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
December 18, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
December 18, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
December 18, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
December 18, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c).
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
December 18, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
November 20, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed
Hazard: Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
October 16, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ N
Hazard: Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
July 31, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Hazard: Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
July 10, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Amm
Hazard: Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
July 10, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: A
Hazard: Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
April 4, 2018DrugsFDA
Amneal Pharmaceuticals recalls Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ
Hazard: Presence of particulate matter
November 22, 2017DrugsFDA
Amneal Pharmaceuticals LLC recalls Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Am
Hazard: Presence of Particulate Matter
May 10, 2017DrugsFDA
Amneal Pharmaceuticals LLC recalls Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162
Hazard: Failed Dissolution Specifications