⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Unichem Pharmaceuticals USA Inc.: Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LT

DrugsSource: FDA (drug) · Date: 2026-02-11

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Unichem Pharmaceuticals USA Inc.
Product
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 / hazard
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide and PR.
Recall initiated
2026-01-21
Code info
Lot # GBHL24005A, Exp Date: 09/2026
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
East Brunswick
State
NJ
Country
United States
Event id
98323
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