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Aurobindo Pharma USA Inc FDA Recalls
21 recalls on file across drugs, 1 of them Class I and 9 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 PClass IIJul 23, 2026shortfill; reports of empty capsules. |
| Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle,Class IIMay 22, 2025cGMP deviations: Due to confirmed consumer complaints receiv |
| Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-HightstClass IIDec 6, 2024CGMP Deviations: Presence of Nitrosamine Drug Substance Rela |
| Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-Class IINov 7, 2024cGMP Deviations: Presence of N-nitroso Cinacalcet impurity a |
| Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-Class IINov 7, 2024cGMP Deviations: Presence of N-nitroso Cinacalcet impurity a |
| Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-8Class IINov 7, 2024cGMP Deviations: Presence of N-nitroso Cinacalcet impurity a |
| Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, DistribClass IJul 11, 2024Labeling: Missing Label - some bottles are missing the the m |
| Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDClass IIApr 24, 2024Discoloration: Dotted and yellow spots on tablets |
| Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDClass IIApr 24, 2024Discoloration: Dotted and yellow spots on tablets |
| Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-127Class IIAug 2, 2023Failed dissolution specifications - results obtained were be |
| Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Class IIJul 21, 2023cGMP deviations: Batch was released prior to approval. |
| Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Class IIJul 21, 2023cGMP deviations: Batch was released prior to approval. |
| Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: WalgClass IIMay 22, 2023Failed Impurities/Degradation Specifications: firm's investi |
| Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, IncClass IIOct 5, 2022CGMP Deviations: Detection of N-Nitroso-quinapril impurity a |
| Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for AClass IIIApr 5, 2022Subpotent Drug: Out of Specification results for Assay |
| Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, IncClass IIJan 14, 2022Failed Impurities/Degradation Specifications |
| Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC Class IIDec 29, 2021Superpotent and Failed Tablet/Capsule Specifications |
| Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Class IIINov 15, 2021Failed Impurities/Degradation Specifications |
| Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 PrincClass IISep 9, 2021Presence of Foreign Substance: Product complaints received f |
| Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: AuroClass IIJul 7, 2021Presence of Foreign Substance- Potential of metal contaminat |
| Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HighClass IIJan 20, 2021Presence of foreign tablets/capsules: Famotidine 20mg and ib |