Class II Recall — Risk of Temporary or Reversible Adverse Health Consequences

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-co Recall 2026

Official title: 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

MedicationsBy Recall Watch Editorial TeamJanuary 21, 2026Updated April 16, 2026

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),...

FDAClass II — Possible Riskdrug

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

Affected Lot Numbers

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

Lot Number
Lot # GBHL24005A
Exp Date: 09/2026

Why it was recalled

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

Where was it sold

US Nationwide and PR.

nationwide

What to do

  1. Do not consume or use this product
  2. Check the lot numbers or UPC codes listed above
  3. Return the product to the store where you purchased it for a full refund
  4. Contact your healthcare provider if you have experienced any symptoms
View official FDA notice

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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.

Why was BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE recalled in 2026?

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