East Windsor, NJ, United States
Aurobindo Pharma USA Inc. recalls
31 recalls recorded since 2018, most recently on 18 September 2026. 9 are listed as ongoing. Status and classification are as published by the FDA.
Recalls31
Ongoing (FDA)9
Terminated or completed22
Class I (FDA)3
Ongoing Not Yet Classified Drugs
- Recall started
- 18 September 2026
- Reason
- Discoloration: consumer complaints received for discolored tablets
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, Made in India, NDC 72288-692-01. UPC 1 95515 04888 0
Ongoing Class II Drugs
- Recall started
- 23 July 2026
- Reason
- shortfill; reports of empty capsules.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0733-2026
- Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
Ongoing Class II Drugs
- Recall started
- 22 May 2025
- Reason
- cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
- Distribution
- USA Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0471-2025
- Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
Ongoing Class II Drugs
- Recall started
- 6 December 2024
- Reason
- CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0149-2025
- Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30
Ongoing Class II Drugs
- Recall started
- 7 November 2024
- Reason
- cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0078-2025, D-0077-2025, D-0079-2025
- Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Wind
- Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Win
- Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Win
Ongoing Class I Drugs
- Recall started
- 11 July 2024
- Reason
- Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
- Distribution
- NJ, NY & PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0641-2024
- Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-
Ongoing Class II Drugs
- Recall started
- 24 April 2024
- Reason
- Discoloration: Dotted and yellow spots on tablets
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0492-2024, D-0491-2024
- Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, E
- Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, E
Terminated Class II Drugs
- Recall started
- 2 August 2023
- Terminated
- 19 August 2024
- Reason
- Failed dissolution specifications - results obtained were below spec average.
- Distribution
- USA nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1171-2023
- Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Terminated Class II Drugs
- Recall started
- 21 July 2023
- Terminated
- 26 February 2024
- Reason
- cGMP deviations: Batch was released prior to approval.
- Distribution
- USA nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1088-2023, D-1087-2023
- Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08
- Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-616-08
Completed Class II Drugs
- Recall started
- 22 May 2023
- Reason
- Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
- Distribution
- The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0765-2023
- Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.
Completed Class II Drugs
- Recall started
- 5 October 2022
- Reason
- CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0021-2023
- Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90
Terminated Class III Drugs
- Recall started
- 5 April 2022
- Terminated
- 27 June 2024
- Reason
- Subpotent Drug: Out of Specification results for Assay
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0766-2022
- Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.
Terminated Class II Drugs
- Recall started
- 14 January 2022
- Terminated
- 31 July 2024
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0560-2022
- Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03
Terminated Class II Drugs
- Recall started
- 29 December 2021
- Terminated
- 4 December 2023
- Reason
- Superpotent and Failed Tablet/Capsule Specifications
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0450-2022
- Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
Terminated Class III Drugs
- Recall started
- 15 November 2021
- Terminated
- 23 August 2023
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0263-2022
- Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05
Terminated Class II Drugs
- Recall started
- 9 September 2021
- Terminated
- 31 October 2023
- Reason
- Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0812-2021
- Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99
Terminated Class II Drugs
- Recall started
- 7 July 2021
- Terminated
- 18 October 2023
- Reason
- Presence of Foreign Substance- Potential of metal contamination.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0719-2021
- Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 6586
Terminated Class II Drugs
- Recall started
- 20 January 2021
- Terminated
- 12 October 2023
- Reason
- Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
- Distribution
- TX, CA, GA, PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0290-2021
- Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99
Terminated Class III Drugs
- Recall started
- 22 October 2020
- Terminated
- 4 April 2023
- Reason
- Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
- Distribution
- NJ
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0065-2021
- Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made
Terminated Class II Drugs
- Recall started
- 10 August 2020
- Terminated
- 28 June 2024
- Reason
- Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1535-2020
- Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in In
Terminated Class II Drugs
- Recall started
- 12 June 2020
- Terminated
- 21 December 2022
- Reason
- Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1370-2020
- Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05
Terminated Class III Drugs
- Recall started
- 26 May 2020
- Terminated
- 10 January 2023
- Reason
- Failed Impurities/ Degradation Specifications
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1315-2020, D-1314-2020
- Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30
- Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
Terminated Class II Drugs
- Recall started
- 18 March 2020
- Terminated
- 25 March 2024
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1232-2020, D-1231-2020, D-1229-2020, D-1236-2020, D-1233-2020, D-1237-2020, D-1235-2020, D-1234-2020, D-1230-2020
- Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
- Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
- Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
- Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01
- Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08
- Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
- Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
- Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
- and 1 more product lines
Terminated Class II Drugs
- Recall started
- 19 September 2019
- Terminated
- 4 April 2023
- Reason
- Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0143-2020
- Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobin
Terminated Class III Drugs
- Recall started
- 29 July 2019
- Terminated
- 28 October 2021
- Reason
- Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
- Distribution
- Product was distributed nationwide by three major distributors who may have further distributed the product.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1842-2019
- Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
Terminated Class I Drugs
- Recall started
- 28 March 2019
- Terminated
- 11 April 2024
- Reason
- Presence of Particulate Matter: One vial was found to contain a hair.
- Distribution
- Product is being held at a distributor site in Mexico, Asheboro, NC, Charlotte, NC and Santa Teresa, NM and not further distributed in the U.S. Market.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1248-2019
- Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05
Ongoing Class II Drugs
- Recall started
- 31 December 2018
- Reason
- 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.
- Distribution
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0370-2019, D-0364-2019, D-0369-2019, D-0366-2019, D-0363-2019, D-0367-2019, D-0365-2019, D-0361-2019, D-0368-2019, D-0362-2019
- Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
- Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.
- Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.
- Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.
- Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.
- Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.
- Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.
- Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30
- and 2 more product lines
Ongoing Class II Drugs
- Recall started
- 31 December 2018
- Reason
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1037-2019, D-1036-2019, D-1039-2019, D-1035-2019, D-1038-2019
- Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30
- Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30
- Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
- Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90
- Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
Terminated Class III Drugs
- Recall started
- 30 November 2018
- Terminated
- 1 February 2022
- Reason
- 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).
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0289-2019
- Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30
Terminated Class III Drugs
- Recall started
- 2 February 2018
- Terminated
- 18 February 2021
- Reason
- Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
- Distribution
- Nationwide within the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0427-2018
- Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) M
Terminated Class I Drugs
- Recall started
- 2 January 2018
- Terminated
- 10 September 2019
- Reason
- Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
- Distribution
- distributed nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0339-2018
- Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.