Unichem Pharmaceuticals USA Inc. 2026-02-11 Health serious FDA
Health · FDA · Recall #FDA-D-0301-2026
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count… Recall
Issued February 11, 2026 · Unichem Pharmaceuticals USA Inc.
In February 2026, Unichem Pharmaceuticals USA Inc. recalled the Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
What you should do
- 1 Stop using Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Unichem Pharmaceuticals USA Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Unichem Pharmaceuticals USA Inc.
- Category
- Health
- Recall date
- February 11, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide and PR.
- Recall number
- FDA-D-0301-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Unichem Pharmaceuticals USA Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.