BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-co Recall 2026
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEIssued January 21, 2026
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..
What to do about this recall
- Agency
- FDA
- Issued
- Jan 21, 2026
- Brand
- BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
- Distribution
- 1 states
- Lots affected
- 2
Steps to take for this recall
Stop using it
Take it out of rotation. Don't consume, wear, or operate.
Verify the match
Compare lot numbers, UPCs, and dates against your product.
Return or dispose
Follow the manufacturer's instructions to refund or safely dispose.
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
Why it was recalled
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Affected products & lot numbers2 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 sold1 state
US Nationwide and PR.
More recalls like this4 related — by brand, contaminant, and category
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- F.H. INVESTMENTS, Inc. (dba Asteria Health) ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham Recall 20262026
- F.H. INVESTMENTS, Inc. (dba Asteria Health) ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, Recall 20262026
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.