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Amneal Pharmaceuticals

24 recalls •

• Categories: Prescription Drugs

Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01

Class I - Dangerous

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

Jun 3, 2026 Prescription Drugs Nationwide View Details →

traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.

Class I - Dangerous

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).

Mar 19, 2026 Prescription Drugs Nationwide View Details →

Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3.

Class I - Dangerous

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.

Mar 18, 2026 Prescription Drugs Nationwide View Details →

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.

Class I - Dangerous

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.

Aug 18, 2025 Prescription Drugs Nationwide View Details →

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.

Class I - Dangerous

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.

Aug 18, 2025 Prescription Drugs Nationwide View Details →

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.

Class I - Dangerous

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.

Aug 18, 2025 Prescription Drugs Nationwide View Details →

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

Class I - Dangerous

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.

Aug 18, 2025 Prescription Drugs Nationwide View Details →

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.

Class I - Dangerous

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.

Aug 18, 2025 Prescription Drugs Nationwide View Details →

Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

Class I - Dangerous

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

Jun 2, 2025 Prescription Drugs Nationwide View Details →

Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)

Class I - Dangerous

Presence of Particulate Matter

Apr 17, 2025 Prescription Drugs Nationwide View Details →

Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

Class I - Dangerous

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

Aug 1, 2024 Prescription Drugs Nationwide View Details →

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

Class I - Dangerous

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Nov 22, 2019 Prescription Drugs View Details →

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

Class I - Dangerous

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Nov 22, 2019 Prescription Drugs View Details →

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).

Class I - Dangerous

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Nov 22, 2019 Prescription Drugs View Details →

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

Class I - Dangerous

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Nov 22, 2019 Prescription Drugs View Details →

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

Class I - Dangerous

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Nov 22, 2019 Prescription Drugs View Details →

Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3

Class I - Dangerous

Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.

Oct 16, 2019 Prescription Drugs View Details →

Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10

Class I - Dangerous

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

Sep 24, 2019 Prescription Drugs View Details →

Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)

Class I - Dangerous

Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets

Jul 18, 2019 Prescription Drugs Nationwide View Details →

Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01

Class I - Dangerous

Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.

Sep 25, 2017 Prescription Drugs Nationwide View Details →

Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01

Class I - Dangerous

Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.

Sep 25, 2017 Prescription Drugs Nationwide View Details →

Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1

Class I - Dangerous

Presence of particulate matter

Dec 15, 2017 Prescription Drugs Nationwide View Details →

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7

Class I - Dangerous

Presence of Particulate Matter

Aug 31, 2017 Prescription Drugs View Details →

Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807

Class I - Dangerous

Failed Dissolution Specifications

Dec 12, 2016 Prescription Drugs Nationwide View Details →