Aurobindo Pharma USA Inc.

FDA Regulatory Profile

Summary

Total Recalls
58 (2 Class I)
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0471-2025Class IIAcetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 TerryMay 22, 2025
D-0149-2025Class IINebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 2December 6, 2024
D-0077-2025Class IICinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPNovember 7, 2024
D-0079-2025Class IICinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPNovember 7, 2024
D-0078-2025Class IICinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPENovember 7, 2024
D-0641-2024Class IHealthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-coJuly 11, 2024
D-0491-2024Class IIClorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 taApril 24, 2024
D-0492-2024Class IIClorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 taApril 24, 2024
D-1171-2023Class IIRasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 August 2, 2023
D-1088-2023Class IIRufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo PhJuly 21, 2023
D-1087-2023Class IIRufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo PhJuly 21, 2023
D-0765-2023Class IIPain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, May 22, 2023
D-0021-2023Class IIQuinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: AurobOctober 5, 2022
D-0766-2022Class IIICyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, ManufactApril 5, 2022
D-0560-2022Class IIMoxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: AurobJanuary 14, 2022
D-0450-2022Class IIPioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., EastDecember 29, 2021
D-0263-2022Class IIICarvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA November 15, 2021
D-0812-2021Class IIMetoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo PharmSeptember 9, 2021
D-0719-2021Class IISulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, July 7, 2021
D-0290-2021Class IIFamotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, IncJanuary 20, 2021