Is this recall still active?

The FDA lists the recall as ongoing. The recall is still in progress.

Checked Oct 26, 2026

Class IIDrug recallOngoing

Bisoprolol Fumarate and Hydrochlorothiazide tablets recall

Recalled by Unichem Pharmaceuticals USA Inc. of East Brunswick, NJ · FDA report 02/11/2026

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class II; Moderate
Status: Ongoing
Recall started: 01/21/2026
Distribution: Nationwide

Reason for recall

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

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

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 and code info: Lot # GBHL24005A, Exp Date: 09/2026
Brand names: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Recall number: D-0301-2026
Event ID: 98323
Initiated by: Voluntary: Firm initiated

Where it was distributed

US Nationwide and PR.

Nationwide

Recall timeline

01/21/2026Firm started the recall
01/30/2026FDA classified it as Class II
02/11/2026Published in the FDA enforcement report

More recalls from Unichem Pharmaceuticals USA

Frequently asked questions

Why was Bisoprolol Fumarate and Hydrochlorothiazide tablets recalled?: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
What does Class II mean?: Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Where was the recalled product sold?: US Nationwide and PR.
Is this recall still active?: The FDA lists the recall as ongoing. The recall is still in progress.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 02/11/2026 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class II
Status: Ongoing
Type: Drug
Reported: 02/11/2026

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

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About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

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