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Drug FDA Class II Ongoing cGMP deviation

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

Unichem Pharmaceuticals USA Inc. Published Feb 11, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Unichem Pharmaceuticals USA Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

N-nitroso-bisoprolol · primary

Affected products (1)

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

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE · N/A

NDC: 29300-187, 29300-188, 29300-189, 29300-187-13, 29300-187-01, 29300-187-05, 29300-187-10, 29300-188-13, 29300-188-01, 29300-188-05, 29300-188-10, 29300-189-13, 29300-189-01, 29300-189-05, 29300-189-10
Lot codes: GBHL24005A
Code info: Lot # GBHL24005A, Exp Date: 09/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 21, 2026
  2. Published
    Feb 11, 2026
Recall number
D-0301-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.