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Aurobindo Pharma USA Recalls
59 recalls on record · June 5, 2013 to August 12, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Ph
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Ph
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
April 22, 2020DrugsFDA
Aurobindo Pharma USA Inc. recalls Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Ph
Hazard: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
October 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Sal
Hazard: Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
September 4, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufac
Hazard: Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
April 17, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E
Hazard: Presence of Particulate Matter: One vial was found to contain a hair.
March 27, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
March 27, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 6
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
March 27, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
March 27, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton,
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
March 27, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810.
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharm
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharm
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharm
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharm
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, In
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, In
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
January 23, 2019DrugsFDA
Aurobindo Pharma USA Inc. recalls Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, In
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
December 12, 2018DrugsFDA
Aurobindo Pharma USA Inc. recalls Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA,
Hazard: Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
February 22, 2017DrugsFDA
Aurobindo Pharma USA Inc recalls Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pha
Hazard: Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
February 15, 2017DrugsFDA
Aurobindo Pharma USA Inc recalls Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC
Hazard: Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
September 21, 2016DrugsFDA
Aurobindo Pharma USA Inc recalls Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma
Hazard: Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
January 14, 2015DrugsFDA
Aurobindo Pharma USA Inc recalls Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manu
Hazard: Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
June 5, 2013DrugsFDA
Aurobindo Pharma USA Inc recalls Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400
Hazard: Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label