Aurobindo Pharma USA Inc. Provisional
FDA Flags (19)
Class II RecallJun 2025
Aurobindo Pharma USA Inc
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle,
Classification: Class II
Class II RecallDec 2024
Aurobindo Pharma USA Inc
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightst
Classification: Class II
Class II RecallDec 2024
Aurobindo Pharma USA Inc
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-8
Classification: Class II
Class II RecallDec 2024
Aurobindo Pharma USA Inc
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-
Classification: Class II
Class II RecallDec 2024
Aurobindo Pharma USA Inc
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-
Classification: Class II
Class I RecallAug 2024
Aurobindo Pharma USA Inc
Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distrib
Classification: Class I
Class II RecallMay 2024
Aurobindo Pharma USA Inc.
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, ND
Classification: Class II
Class II RecallMay 2024
Aurobindo Pharma USA Inc.
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, ND
Classification: Class II
Class II RecallSep 2023
Aurobindo Pharma USA Inc.
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-127
Classification: Class II
Class II RecallAug 2023
Aurobindo Pharma USA Inc.
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279
Classification: Class II
Class II RecallAug 2023
Aurobindo Pharma USA Inc.
Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279
Classification: Class II
Class II RecallMay 2023
Aurobindo Pharma USA Inc.
Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walg
Classification: Class II
Class II RecallNov 2022
Aurobindo Pharma USA Inc.
Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc
Classification: Class II
Class III RecallApr 2022
Aurobindo Pharma USA Inc.
Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for A
Classification: Class III
Class II RecallFeb 2022
Aurobindo Pharma USA Inc.
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc
Classification: Class II
Class II RecallFeb 2022
Aurobindo Pharma USA Inc.
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC
Classification: Class II
Class III RecallDec 2021
Aurobindo Pharma USA Inc.
Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-
Classification: Class III
Class II RecallSep 2021
Aurobindo Pharma USA Inc.
Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princ
Classification: Class II
Class II RecallAug 2021
Aurobindo Pharma USA Inc.
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Auro
Classification: Class II