UNICHEM PHARMACEUTICALS USA INC

FDA Regulatory Profile

Summary

Total Recalls
11 (1 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Known Names

unichem pharmaceuticals usa, unichem pharmaceuticals (usa)

Recent Recalls

NumberClassProductDate
D-0306-2026Class IIIDoxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem PharmaceuticaJanuary 21, 2026
D-0301-2026Class IIBisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only,January 21, 2026
D-0655-2025Class ICyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: UniAugust 27, 2025
D-1541-2022Class IIIClonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LASeptember 19, 2022
D-0255-2022Class IIITopiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTDOctober 25, 2021
D-1291-2020Class IIIClonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem LabMay 26, 2020
D-0829-2020Class IIIClonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem LaboJanuary 29, 2020
D-0228-2018Class IIDivalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: UDecember 19, 2017
D-0010-2018Class IIBisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIEOctober 2, 2017
D-1519-2016Class IIILamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem LAugust 19, 2016
D-1352-2015Class IIHydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATOJuly 30, 2015