--- title: "UNICHEM PHARMACEUTICALS USA INC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search UNICHEM PHARMACEUTICALS 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/unichem-pharmaceuticals-usa-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # UNICHEM PHARMACEUTICALS USA INC recall records **4** reported ongoing 6 records in this archive. Latest source date Apr 13, 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 Apr 13, 2026 FDA drug enforcement ### [busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured ...](https://isitonrecall.com/recall/fda-drug-d-0511-2026-buspirone-hydrochloride-tablets-usp-5-mg-500-count-bottle-rx-only-manufactured-by-unichem-laboratori/) Subpotent drug Class III Reported ongoing Distribution: USA Nationwide [Official source for busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem La...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0511-2026%22) Jan 21, 2026 FDA drug enforcement ### [Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bar...](https://isitonrecall.com/recall/fda-drug-d-0301-2026-bisoprolol-fumarate-and-hydrochlorothiazide-tablets-usp-2-5-mg-6-25-mg-100-count-bottle-rx-only-manu/) cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. Class II Reported ongoing Distribution: US Nationwide and PR. [Official source for Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx On...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0301-2026%22) Jan 21, 2026 FDA drug enforcement ### [Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 0881...](https://isitonrecall.com/recall/fda-drug-d-0306-2026-doxazosin-tablets-usp-4-mg-1000-tablets-per-bottle-rx-only-distributed-by-unichem-pharmaceuticals-us/) Tablets/Capsules Imprinted with Wrong ID Class III Reported ongoing Distribution: Nationwide [Official source for Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceut...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0306-2026%22) Aug 27, 2025 FDA drug enforcement ### [Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufa...](https://isitonrecall.com/recall/fda-drug-d-0655-2025-cyclobenzaprine-hydrochloride-tablets-usp-10-mg-90-count-bottle-rx-only-manufactured-by-unichem-labo/) Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). Class I Reported ongoing Distribution: Nationwide within the U.S.A [Official source for Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Uni...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0655-2025%22) Sep 19, 2022 FDA drug enforcement ### [Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manu...](https://isitonrecall.com/recall/fda-drug-d-1541-2022-clonidine-hydrochloride-tablets-usp-0-3-mg-100-count-bottle-rx-only-manufactured-by-unichem-laborato/) Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets, Class III Reported terminated Distribution: Distributed Nationwide in the USA [Official source for Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1541-2022%22) Oct 25, 2021 FDA drug enforcement ### [Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Uniche...](https://isitonrecall.com/recall/fda-drug-d-0255-2022-topiramate-tablets-usp-50-mg-500-count-bottles-rx-only-manufactured-by-unichem-laboratories-ltd-ind/) Discoloration Class III Reported terminated Distribution: Nationwide within the United States [Official source for Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0255-2022%22) ## Reasons in these listed records - Subpotent drug - cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. - Tablets/Capsules Imprinted with Wrong ID - Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). These examples come from this result page and are not a ranking of every recall reason. ## Checking UNICHEM PHARMACEUTICALS USA INC ### Is there a recall on unichem pharmaceuticals usa inc right now? This archive contains 6 records, including 4 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 UNICHEM PHARMACEUTICALS USA INC](https://isitonrecall.com/check/?q=UNICHEM%20PHARMACEUTICALS%20USA%20INC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)