Bisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity
Unichem Pharmaceuticals USA is recalling a lot of Bisoprolol Fumarate and Hydrochlorothiazide tablets, 2.5 mg/6.25 mg, for not meeting the N-Nitroso Bisoprolol impurity specification limits.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the same criterion applied to other out-of-specification results: the record cites an impurity above its specification limit with no stated clinical consequence or reported harm.
Plain-English summary
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, in 100-count bottles, Rx only, manufactured by Unichem Laboratories Ltd. of Goa, India for Unichem Pharmaceuticals (USA), Inc. of East Brunswick, New Jersey, under NDC 29300-187-01, are being recalled.
The reason given in the enforcement record is cGMP deviations: the recall is due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
The record's quantity field reads 'N/A'. The recall covers lot GBHL24005A, expiry 09/2026. Distribution was nationwide in the US and Puerto Rico. The FDA has classified the action as Class II.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
- Brand
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Unichem Pharmaceuticals USA Inc.
- Category
- Drug — Antihypertensive
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # GBHL24005A
- Exp Date: 09/2026
Distribution
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