--- title: "Aurobindo Pharma USA Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Aurobindo Pharma USA Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/aurobindo-pharma-usa-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Aurobindo Pharma USA Inc. recall records **9** reported ongoing 19 records in this archive. Latest source date Jul 23, 2026. 1 published notices do not supply a closure status. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 23, 2026 FDA drug enforcement ### [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...](https://isitonrecall.com/recall/fda-drug-d-0733-2026-dicyclomine-hydrochloride-capsules-usp-10mg-1-000-bottles-rx-only-distributed-by-aurobindo-pharma-us/) shortfill; reports of empty capsules. Class II Reported ongoing Distribution: US Nationwide. [Official source for Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0733-2026%22) May 22, 2025 FDA drug enforcement ### [Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10](https://isitonrecall.com/recall/fda-drug-d-0471-2025-acetaminophen-tablets-325-mg-100-count-bottles-distributed-by-amazon-com-services-llc-410-terry-aven/) cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). Class II Reported ongoing Distribution: USA Nationwide. [Official source for Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Te...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0471-2025%22) Dec 6, 2024 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0149-2025-nebivolol-tablets-2-5-mg-30-count-bottles-rx-only-distributed-by-aurobindo-pharma-usa-inc-279-prince/) CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc....](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0149-2025%22) Nov 7, 2024 FDA drug enforcement ### [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, I...](https://isitonrecall.com/recall/fda-drug-d-0077-2025-cinacalcet-tablets-30-mg-packaged-in-a-30-count-hdpe-bottle-ndc-65862-831-30-b-500-count-hdpe-bottle/) cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II Reported ongoing Distribution: USA Nationwide [Official source for Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0077-2025%22) Nov 7, 2024 FDA drug enforcement ### [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, In...](https://isitonrecall.com/recall/fda-drug-d-0078-2025-cinacalcet-tablets-60mg-packaged-in-a-30-count-hdpe-bottle-ndc-65862-832-30-b-500-count-hdpe-bottle/) cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II Reported ongoing Distribution: USA Nationwide [Official source for Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count H...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0078-2025%22) Nov 7, 2024 FDA drug enforcement ### [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, I...](https://isitonrecall.com/recall/fda-drug-d-0079-2025-cinacalcet-tablets-90-mg-packaged-in-a-30-count-hdpe-bottle-ndc-65862-833-30-b-500-count-hdpe-bottle/) cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II Reported ongoing Distribution: USA Nationwide [Official source for Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0079-2025%22) Jul 24, 2024 FDA company announcement ### [Healthy Living: Migraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets](https://isitonrecall.com/recall/fdapress-b99d244c8c24ef0d-healthy-living-migraine-relief-acetaminophen-250mg-aspirin-nsaid-250mg-caffeine-65mg-tablets/) Device & Drug Safety - Mislabeling Not supplied Published notice; closure not supplied Distribution: Aurobindo Pharma USA, Inc. began shipping of the subject batch to customers nationwide in January 2024. AuroHealth Over the Counter (OTC) bottle(s) with no label affixed to the ... [Official source for Healthy Living: Migraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-behalf-aurohealth-issues-voluntary-nationwide-recall-one-1-lot-healthy) Jul 11, 2024 FDA drug enforcement ### [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, E...](https://isitonrecall.com/recall/fda-drug-d-0641-2024-healthy-living-acetaminophen-aspirin-nsaid-and-caffeine-tablets-usp-250-mg-250-mg-65-mg-100-count-bo/) Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information. Class I Reported ongoing Distribution: NJ, NY & PA [Official source for Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0641-2024%22) Apr 24, 2024 FDA drug enforcement ### [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 ...](https://isitonrecall.com/recall/fda-drug-d-0491-2024-clorazepate-dipotassium-tablets-usp-3-75-mg-a-100-tablets-per-bottle-ndc-13107-282-01-b-500-tablets/) Discoloration: Dotted and yellow spots on tablets Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0491-2024%22) Apr 24, 2024 FDA drug enforcement ### [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 ...](https://isitonrecall.com/recall/fda-drug-d-0492-2024-clorazepate-dipotassium-tablets-usp-7-5-mg-a-100-tablets-per-bottle-ndc-13107-283-01-b-500-tablets-p/) Discoloration: Dotted and yellow spots on tablets Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0492-2024%22) Aug 2, 2023 FDA drug enforcement ### [Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93](https://isitonrecall.com/recall/fda-drug-d-1171-2023-rasagiline-tablets-0-5mg-30-count-bottle-rx-only-mylan-pharmaceuticals-inc-morgantown-wv-26505-u-s-a/) Failed dissolution specifications - results obtained were below spec average. Class II Reported terminated Distribution: USA nationwide [Official source for Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 265...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1171-2023%22) Jul 21, 2023 FDA drug enforcement ### [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...](https://isitonrecall.com/recall/fda-drug-d-1087-2023-rufinamide-tablets-usp-200-mg-packaged-in-120-count-bottle-rx-only-distributed-by-aurobindo-pharma-u/) cGMP deviations: Batch was released prior to approval. Class II Reported terminated Distribution: USA nationwide [Official source for Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1087-2023%22) Jul 21, 2023 FDA drug enforcement ### [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...](https://isitonrecall.com/recall/fda-drug-d-1088-2023-rufinamide-tablets-usp-400-mg-packaged-in-120-count-bottle-rx-only-distributed-by-aurobindo-pharma-u/) cGMP deviations: Batch was released prior to approval. Class II Reported terminated Distribution: USA nationwide [Official source for Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1088-2023%22) May 22, 2023 FDA drug enforcement ### [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 0363-99...](https://isitonrecall.com/recall/fda-drug-d-0765-2023-pain-reliever-acetaminophen-usp-caplets-500-mg-225-count-bottles-packaged-in-a-cardboard-carton-dist/) Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity. Class II Reported completed Distribution: The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA. [Official source for Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carto...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0765-2023%22) Oct 5, 2022 FDA drug enforcement ### [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, M...](https://isitonrecall.com/recall/fda-drug-d-0021-2023-quinapril-and-hydrochlorothiazide-tablets-usp-20mg-12-5mg-90-tablets-bottles-distributed-by-aurobind/) CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Class II Reported completed Distribution: Nationwide [Official source for Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Au...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0021-2023%22) Apr 5, 2022 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-0766-2022-cyanocobalamin-injection-usp-1-000-mcg-per-ml-for-im-or-sc-use-only-1-ml-vial-rx-only-manufactured-i/) Subpotent Drug: Out of Specification results for Assay Class III Reported terminated Distribution: Nationwide in the USA. [Official source for Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manuf...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0766-2022%22) Jan 14, 2022 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0560-2022-moxifloxacin-ophthalmic-solution-usp-0-5-w-v-3-ml-bottle-sterile-rx-only-distributed-by-aurobindo-ph/) Failed Impurities/Degradation Specifications Class II Reported terminated Distribution: USA Nationwide [Official source for Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Au...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0560-2022%22) Dec 29, 2021 FDA drug enforcement ### [Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05](https://isitonrecall.com/recall/fda-drug-d-0450-2022-pioglitazone-tablets-usp-45-mg-500-count-bottles-distributed-by-aurobindo-pharma-usa-inc-east-windso/) Superpotent and Failed Tablet/Capsule Specifications Class II Reported terminated Distribution: Nationwide in the US [Official source for Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., E...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0450-2022%22) Nov 15, 2021 FDA drug enforcement ### [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, ...](https://isitonrecall.com/recall/fda-drug-d-0263-2022-carvedilol-tablets-usp-6-25-mg-500-tablets-bottle-rx-only-distributed-by-aurobindo-pharma-usa-inc-27/) Failed Impurities/Degradation Specifications Class III Reported terminated Distribution: Nationwide in the US [Official source for Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma U...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0263-2022%22) ## Reasons in these listed records - shortfill; reports of empty capsules. - cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). - CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit. - cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit These examples come from this result page and are not a ranking of every recall reason. ## Checking Aurobindo Pharma USA Inc. ### Is there a recall on aurobindo pharma usa inc. right now? This archive contains 19 records, including 9 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Aurobindo Pharma USA Inc.](https://isitonrecall.com/check/?q=Aurobindo%20Pharma%20USA%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)