Bridgewater, NJ, United States
Amneal Pharmaceuticals, LLC recalls
14 recalls recorded since 2018, most recently on 8 September 2026. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls14
Ongoing (FDA)7
Terminated or completed7
Class I (FDA)3
Ongoing Class II Drugs
- Recall started
- 8 September 2026
- Reason
- Defective Container; packets were found to be either empty or partially full.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0873-2026
- Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.
Ongoing Class III Drugs
- Recall started
- 3 June 2026
- Reason
- Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
- Distribution
- Nationwide within the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0585-2026
- 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
Ongoing Class II Drugs
- Recall started
- 19 March 2026
- Reason
- 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).
- Distribution
- Nationwide within the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0408-2026
- 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 6021
Ongoing Class I Drugs
- Recall started
- 18 March 2026
- Reason
- 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.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0478-2026
- 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
Ongoing Class II Drugs
- Recall started
- 18 August 2025
- Reason
- 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.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0619-2025, D-0618-2025, D-0616-2025, D-0615-2025, D-0617-2025
- 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
- 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 LL
- 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
- 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, Pv
- 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,
Ongoing Class I Drugs
- Recall started
- 2 June 2025
- Reason
- Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0488-2025
- 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 S
Terminated Class I Drugs
- Recall started
- 17 April 2025
- Terminated
- 5 October 2026
- Reason
- Presence of Particulate Matter
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0402-2025
- 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 7012
Completed Class III Drugs
- Recall started
- 1 August 2024
- Reason
- Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0629-2024
- Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
Ongoing Class II Drugs
- Recall started
- 22 November 2019
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0613-2020, D-0616-2020, D-0612-2020, D-0615-2020, D-0614-2020
- 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).
- Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
- 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
- Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
- Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Terminated Class III Drugs
- Recall started
- 16 October 2019
- Terminated
- 9 November 2020
- Reason
- Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
- Distribution
- Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0321-2020
- 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
Terminated Class III Drugs
- Recall started
- 24 September 2019
- Terminated
- 4 March 2021
- Reason
- Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
- Distribution
- Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0134-2020
- Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
Terminated Class III Drugs
- Recall started
- 18 July 2019
- Terminated
- 22 April 2020
- Reason
- Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
- Distribution
- Product was distributed to three major distributors who may have further distributed the product nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1516-2019
- Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Terminated Class II Drugs
- Recall started
- 15 December 2017
- Terminated
- 3 August 2020
- Reason
- Presence of particulate matter
- Distribution
- U.S.A Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0610-2018
- Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
Terminated Class III Drugs
- Recall started
- 25 September 2017
- Terminated
- 8 August 2019
- Reason
- Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1439-2019, D-1438-2019
- 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 08
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.