January 2026 FDA Recall Bisoprolol Fumarate And Hydrochlorothiazide by Unichem Pharmaceuticals Usa Inc.
D-0301-2026 - cGMP Deviations
This Class II drug recall was voluntarily initiated by Unichem Pharmaceuticals Usa Inc. on January 21, 2026 for the product Bisoprolol Fumarate And Hydrochlorothiazide. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0301-2026
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
01-21-2026
02-11-2026
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Unichem Pharmaceuticals USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide and PR.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# GBHL24005A, Exp Date: 09/2026
