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Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 Recall 2026

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEIssued January 21, 2026Updated Reviewed by the Recall Watch editorial team

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE 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 — recalled per FDA on 1/21/2026. Reason: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits..

Agency
FDA
Issued
Jan 21, 2026
Brand
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Distribution
1 states
Lots affected
2
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued January 21, 2026 · Last synced Apr 16, 2026

What's recalled

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

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Why it was recalled

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

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot # GBHL24005A
Exp Date: 09/2026
Where was it sold
1 state

US Nationwide and PR.

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE recall still active?

Yes, this recall is currently active as of January 21, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot # GBHL24005A, Exp Date: 09/2026. Check the label on your product.

What should I do if I have the recalled BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.