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.
What this means for you
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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