--- title: "ANI Pharmaceuticals, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search ANI Pharmaceuticals, 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/ani-pharmaceuticals-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # ANI Pharmaceuticals, Inc. recall records **2** reported ongoing 7 records in this archive. Latest source date Jun 2, 2026. 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 Jun 2, 2026 FDA drug enforcement ### [hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10](https://isitonrecall.com/recall/fda-drug-d-0619-2026-hydroxyzine-hydrochloride-oral-solution-usp-10-mg-5-ml-473-ml-1-pint-rx-only-distributed-by-ani-phar/) Presence of foreign substance Class III Reported ongoing Distribution: Nationwide in the USA [Official source for hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed b...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0619-2026%22) May 12, 2026 FDA drug enforcement ### [Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20](https://isitonrecall.com/recall/fda-drug-d-0543-2026-estradiol-gel-0-1-0-25-mg-0-25-g-per-packet-30-packets-per-carton-rx-only-distributed-by-ani-pharmac/) Defective Container; packets were found to be either empty or partially full. Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0543-2026%22) Feb 15, 2022 FDA drug enforcement ### [Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx o...](https://isitonrecall.com/recall/fda-drug-d-0564-2022-alprazolam-tablets-usp-0-25-mg-packaged-in-a-100-count-bottles-ndc-67253-900-10-b-500-count-bottles/) cGMP Deviations Class II Reported terminated Distribution: Nationwide within the United States [Official source for Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-coun...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0564-2022%22) Feb 15, 2022 FDA drug enforcement ### [Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx on...](https://isitonrecall.com/recall/fda-drug-d-0565-2022-alprazolam-tablets-usp-0-5-mg-packaged-in-a-100-count-bottles-ndc-67253-901-10-b-500-count-bottles-n/) cGMP Deviations Class II Reported terminated Distribution: Nationwide within the United States [Official source for Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0565-2022%22) Feb 15, 2022 FDA drug enforcement ### [Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx on...](https://isitonrecall.com/recall/fda-drug-d-0566-2022-alprazolam-tablets-usp-1-0-mg-packaged-in-a-100-count-bottles-ndc-67253-902-10-b-500-count-bottles-n/) cGMP Deviations Class II Reported terminated Distribution: Nationwide within the United States [Official source for Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0566-2022%22) Feb 15, 2022 FDA drug enforcement ### [Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnu...](https://isitonrecall.com/recall/fda-drug-d-0567-2022-alprazolam-tablets-usp-2-0-mg-packaged-in-a-100-count-bottles-ndc-67253-903-10-b-500-count-bottles-n/) cGMP Deviations Class II Reported terminated Distribution: Nationwide within the United States [Official source for Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0567-2022%22) Feb 15, 2022 FDA drug enforcement ### [Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge...](https://isitonrecall.com/recall/fda-drug-d-0568-2022-pyrazinamide-tablets-usp-500-mg-100-count-bottles-rx-only-manufactured-by-ultratab-laboratories-inc/) cGMP Deviations Class II Reported terminated Distribution: Nationwide within the United States [Official source for Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laborator...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0568-2022%22) ## Reasons in these listed records - Presence of foreign substance - Defective Container; packets were found to be either empty or partially full. - cGMP Deviations These examples come from this result page and are not a ranking of every recall reason. ## Checking ANI Pharmaceuticals, Inc. ### Is there a recall on ani pharmaceuticals, inc. right now? This archive contains 7 records, including 2 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 ANI Pharmaceuticals, Inc.](https://isitonrecall.com/check/?q=ANI%20Pharmaceuticals%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)