Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UN
Summary
The FDA issued a Class II for Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-co by Unichem Pharmaceuticals USA Inc.. Reason: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits..
Details
Source
Drug Recall
External ID
D-0301-2026
Action Date
2026-02-11
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot # GBHL24005A, Exp Date: 09/2026
Quantity Affected: N/A
Reason for Recall
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Distribution
US Nationwide and PR.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-21
Company
East Brunswick, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 40 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Unichem Pharmaceuticals USA Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Unichem Pharmaceuticals USA Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Unichem Pharmaceuticals USA Inc. have FDA actions?
Unichem Pharmaceuticals USA Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0301-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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