Aurobindo Pharma recalls
FDA enforcement reports naming Aurobindo Pharma LTD as the recalling firm.
- Recall reports
- 62
- Class I (serious)
- 3
- Most recent report
- Aug 12, 2026
- Aug 12, 2026Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by:…Drug · Aurobindo Pharma USA Incshortfill; reports of empty capsules.Class II
- Jun 25, 2025Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: AmazonDrug · Aurobindo Pharma USA InccGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).Class II
- Dec 25, 2024Nebivolol Tablets, 2Drug · Aurobindo Pharma USA IncCGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.Class II
- Dec 11, 2024Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30)Drug · Aurobindo Pharma USA InccGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limitClass II
- Dec 11, 2024Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b)…Drug · Aurobindo Pharma USA InccGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limitClass II
- Dec 11, 2024Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 5…Drug · Aurobindo Pharma USA InccGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limitClass II
- Aug 28, 2024Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/…Drug · Aurobindo Pharma USA IncLabeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.Class I
- May 15, 2024Clorazepate Dipotassium Tablets, USP, 3Drug · Aurobindo Pharma USA Inc.Discoloration: Dotted and yellow spots on tabletsClass II
- May 15, 2024Clorazepate Dipotassium Tablets, USP, 7Drug · Aurobindo Pharma USA Inc.Discoloration: Dotted and yellow spots on tabletsClass II
- Sep 27, 2023Rasagiline Tablets 0Drug · Aurobindo Pharma USA Inc.Failed dissolution specifications - results obtained were below spec average.Class II
- Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by:…
- Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by:…
- Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardb…
- Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12
- Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx O…
- Moxifloxacin Ophthalmic Solution, USP 0
- Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma US…
- Carvedilol Tablets, USP, 6
- Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Au…
- Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablet…
- Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Ph…
- Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Relie…
- Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tabl…
- Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobin…
- Olanzapine Tablets, USP 2
- Olanzapine Tablets, USP 7
- Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pha…
- Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Phar…
- Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Dist…
- Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobi…
- Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo…
- Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx O…
- Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx O…
- Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx O…
- Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobind…
- Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphe…
- Simvastatin Tablets, USP 40 mg
- Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd
- Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pha…
- Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Phar…
- Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharm…
- Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Phar…
- Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Au…
- Valsartan and Hydrochlorothiazide tablets USP 320mg/12
- Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactur…
- Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactu…
- Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactu…
- Amlodipine and Valsartan Tablets USP 10 mg/320 mg
- Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Ph…
- Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, M…
- Valsartan and Hydrochlorothiazide tablets USP 80 mg/12
- Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only,…
- Valsartan and Hydrochlorothiazide tablets USP 160mg/12
- Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Dist…
- Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufacture…
- Ampicillin and Sulbactam for Injection 1
- Venlafaxine Hydrochloride extended release capsules, 37
- Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd
- Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle,…
- Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northsta…
- Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets
- Northstar Zolpidem Tartrate Tablets USP 10 mg
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