Amneal Pharmaceuticals LLC

FDA Regulatory Profile

Summary

Total Recalls
21 (2 Class I)
510(k) Clearances
0
Inspections
25
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0618-2025Class IIchlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: AmneAugust 18, 2025
D-0615-2025Class IISulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a)August 18, 2025
D-0616-2025Class IIchlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: AmneaAugust 18, 2025
D-0619-2025Class IIchlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: AmneaAugust 18, 2025
D-0617-2025Class IIchlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: AmnealAugust 18, 2025
D-0488-2025Class ISulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDJune 2, 2025
D-0402-2025Class IRopivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal April 17, 2025
D-0629-2024Class IIIMethotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals August 1, 2024
D-0614-2020Class IIRanitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.November 22, 2019
D-0616-2020Class IIRanitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.November 22, 2019
D-0615-2020Class IIRanitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.November 22, 2019
D-0612-2020Class IIRanitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 6November 22, 2019
D-0613-2020Class IIRanitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 6November 22, 2019
D-0321-2020Class IIIIsotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 CapOctober 16, 2019
D-0134-2020Class IIIBenazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal PharmaceuticalsSeptember 24, 2019
D-1516-2019Class IIIMethylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottlesJuly 18, 2019
D-0610-2018Class IIFosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal BiosciencDecember 15, 2017
D-1439-2019Class IIIEsterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, September 25, 2017
D-1438-2019Class IIIEsterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx OnlySeptember 25, 2017
D-0076-2018Class IIFosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx OnlyAugust 31, 2017