Home / Recalls / Unichem Pharmaceuticals USA Inc. / D-0301-2026

D-0301-2026 Class II Ongoing

Recalled by Unichem Pharmaceuticals USA Inc. — East Brunswick, NJ

Recall Details

Product Type
Drugs
Report Date
February 11, 2026
Initiation Date
January 21, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

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, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01

Reason for Recall

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

Distribution Pattern

US Nationwide and PR.

Code Information

Lot # GBHL24005A, Exp Date: 09/2026

Other recalls by Unichem Pharmaceuticals USA Inc.

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  • D-0655-2025 Class I — Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, (August 27, 2025)
  • D-1541-2022 Class III — Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufac (September 19, 2022)
  • D-0255-2022 Class III — Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unic (October 25, 2021)
  • D-1291-2020 Class III — Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufact (May 26, 2020)
  • D-0829-2020 Class III — Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactu (January 29, 2020)
  • D-0228-2018 Class II — Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only (December 19, 2017)
  • D-0010-2018 Class II — Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: (October 2, 2017)
  • D-1519-2016 Class III — Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufa (August 19, 2016)
  • D-1352-2015 Class II — Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured (July 30, 2015)