Aurobindo Pharma recalls

15 official recalls and safety alerts involving Aurobindo Pharma since 2021-12, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Aurobindo Pharma or the relevant agency.

1. 2026-10-07
2. US
   Drugs & medicalNot Yet Classified

   Aurobindo Pharma USA Inc recalls amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N.,…

   Discoloration: consumer complaints received for discolored tablets

   FDA · DrugAurobindo Pharma USA IncUS Nationwide.Official notice →
3. 2026-08-12
4. US
   Drugs & medicalClass II

   Aurobindo Pharma USA Inc recalls Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…

   shortfill; reports of empty capsules.

   FDA · DrugAurobindo Pharma USA IncUS Nationwide.Official notice →
5. 2025-06-25
6. US
   Drugs & medicalClass II

   Aurobindo Pharma USA Inc recalls Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC…

   cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

   FDA · DrugAurobindo Pharma USA IncUSA Nationwide.Official notice →
7. 2024-12-25
8. US
   Drugs & medicalClass II

   Aurobindo Pharma USA Inc recalls Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East…

   CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

   FDA · DrugAurobindo Pharma USA IncNationwide in the USAOfficial notice →
9. 2024-12-11
10. US
    Drugs & medicalClass II

    Aurobindo Pharma USA Inc recalls 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,…

    cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

    FDA · DrugAurobindo Pharma USA IncUSA NationwideOfficial notice →
11. 2024-08-28
12. US
    Drugs & medicalClass I

    Aurobindo Pharma USA Inc recalls Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by:…

    Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.

    FDA · DrugAurobindo Pharma USA IncNJ, NY & PAOfficial notice →
13. 2024-05-15
14. US
    Drugs & medicalClass II

    Aurobindo Pharma USA Inc. recalls Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC…

    Discoloration: Dotted and yellow spots on tablets

    FDA · DrugAurobindo Pharma USA Inc.Nationwide in the USAOfficial notice →
15. 2023-09-27
16. US
    Drugs & medicalClass II

    Aurobindo Pharma USA Inc. recalls Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93

    Failed dissolution specifications - results obtained were below spec average.

    FDA · DrugAurobindo Pharma USA Inc.USA nationwideOfficial notice →
17. 2023-08-30
18. US
    Drugs & medicalClass II

    Aurobindo Pharma USA Inc. recalls Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…

    cGMP deviations: Batch was released prior to approval.

    FDA · DrugAurobindo Pharma USA Inc.USA nationwideOfficial notice →
19. 2023-05-31
20. US
    Drugs & medicalClass II

    Aurobindo Pharma USA Inc. recalls Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200…

    Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.

    FDA · DrugAurobindo Pharma USA Inc.The recalled product was distributed to one Retail Distributor (Walgreens) who…Official notice →
21. 2022-11-02
22. US
    Drugs & medicalClass II

    Aurobindo Pharma USA Inc. recalls Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279…

    CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

    FDA · DrugAurobindo Pharma USA Inc.NationwideOfficial notice →
23. 2022-04-20
24. US
    Drugs & medicalClass III

    Aurobindo Pharma USA Inc. recalls Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics…

    Subpotent Drug: Out of Specification results for Assay

    FDA · DrugAurobindo Pharma USA Inc.Nationwide in the USA.Official notice →
25. 2022-02-23
26. US
    Drugs & medicalClass II

    Aurobindo Pharma USA Inc. recalls Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East…

    Failed Impurities/Degradation Specifications

    FDA · DrugAurobindo Pharma USA Inc.USA NationwideOfficial notice →
27. 2022-02-02
28. US
    Drugs & medicalClass II

    Aurobindo Pharma USA Inc. recalls Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05

    Superpotent and Failed Tablet/Capsule Specifications

    FDA · DrugAurobindo Pharma USA Inc.Nationwide in the USOfficial notice →
29. 2021-12-01
30. US
    Drugs & medicalClass III

    Aurobindo Pharma USA Inc. recalls Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown…

    Failed Impurities/Degradation Specifications

    FDA · DrugAurobindo Pharma USA Inc.Nationwide in the USOfficial notice →