Aurobindo Pharma USA Inc.: 45 recalls on record

Recalls filed with 1 agency: FDA (45).

First recall on record: June 5, 2013. Most recent: August 12, 2026.

Risk classification: Class I: 2 · Class II: 35 · Class III: 8

Most recent recalls

DateAgencyProduct
August 12, 2026FDADicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Au…D-0733-2026
June 25, 2025FDAAcetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC…D-0471-2025
December 25, 2024FDANebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma U…D-0149-2025
December 11, 2024FDACinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 50…D-0077-2025
December 11, 2024FDACinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 50…D-0079-2025
December 11, 2024FDACinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500…D-0078-2025
August 28, 2024FDAHealthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65…D-0641-2024
May 15, 2024FDAClorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-0…D-0491-2024
May 15, 2024FDAClorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01…D-0492-2024
September 27, 2023FDARasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown…D-1171-2023
August 30, 2023FDARufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: A…D-1088-2023
August 30, 2023FDARufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: A…D-1087-2023
May 31, 2023FDAPain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboa…D-0765-2023
November 2, 2022FDAQuinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distribute…D-0021-2023
April 20, 2022FDACyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Onl…D-0766-2022
February 23, 2022FDAMoxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distribute…D-0560-2022
February 2, 2022FDAPioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA,…D-0450-2022
September 29, 2021FDAMetoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Auro…D-0812-2021
August 18, 2021FDASulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets,…D-0719-2021
March 10, 2021FDAFamotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Phar…D-0290-2021
November 11, 2020FDAFluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Relieve…D-0065-2021
September 2, 2020FDASulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablet…D-1535-2020
July 1, 2020FDAClozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo…D-1370-2020
June 24, 2020FDAOlanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Labora…D-1315-2020
June 24, 2020FDAOlanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Labora…D-1314-2020

Questions about this company

How many recalls does Aurobindo Pharma USA Inc. have?
Recalert has 45 U.S. recalls on record for Aurobindo Pharma USA Inc., published between June 5, 2013 and August 12, 2026.
What was the most recent Aurobindo Pharma USA Inc. recall?
FDA recall D-0733-2026, published August 12, 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-…
Which agencies have handled Aurobindo Pharma USA Inc. recalls?
Aurobindo Pharma USA Inc. appears as the recalling firm in recalls from: FDA (45).

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