FDA Recall D-0301-2026

Unichem Pharmaceuticals USA Inc. · East Brunswick, NJ

Class II Ongoing 113 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot # GBHL24005A, Exp Date: 09/2026

Quantity: N/A

Reason for recall

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

Recall record

Recall number: D-0301-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide and PR.
Recall initiated: 2026-01-21
Classified by FDA Center: 2026-01-30
FDA published: 2026-02-11
Recalling firm: Unichem Pharmaceuticals USA Inc.
Firm location: East Brunswick, NJ

Drug identification

Brand name(s): BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Generic name(s): BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Manufacturer(s): Unichem Pharmaceuticals (USA), Inc.
NDC(s): 29300-187, 29300-188, 29300-189
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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