Unichem Pharmaceuticals USA Inc.: 11 recalls on record

Recalls filed with 1 agency: FDA (11).

First recall on record: October 5, 2016. Most recent: May 13, 2026.

Risk classification: Class I: 1 · Class II: 3 · Class III: 7

Most recent recalls

DateAgencyProduct
May 13, 2026FDAbusPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Un…D-0511-2026
February 18, 2026FDADoxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Ph…D-0306-2026
February 11, 2026FDABisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottl…D-0301-2026
September 24, 2025FDACyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactu…D-0655-2025
September 28, 2022FDAClonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by:…D-1541-2022
December 1, 2021FDATopiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Labor…D-0255-2022
June 17, 2020FDAClonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: …D-1291-2020
February 12, 2020FDAClonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: U…D-0829-2020
January 24, 2018FDADivalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufac…D-0228-2018
October 25, 2017FDABisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM …D-0010-2018
October 5, 2016FDALamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by…D-1519-2016

Questions about this company

How many recalls does Unichem Pharmaceuticals USA Inc. have?
Recalert has 11 U.S. recalls on record for Unichem Pharmaceuticals USA Inc., published between October 5, 2016 and May 13, 2026.
What was the most recent Unichem Pharmaceuticals USA Inc. recall?
FDA recall D-0511-2026, published May 13, 2026: 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 for: Unichem Pharmaceu…
Which agencies have handled Unichem Pharmaceuticals USA Inc. recalls?
Unichem Pharmaceuticals USA Inc. appears as the recalling firm in recalls from: FDA (11).

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