FDA recall, , Moderate risk
Unichem Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Bisoprolol Fumarate and Hydrochlorothiazide tablets fail to meet impurity specification limits.
Summary by Recall Canary from the FDA notice
What happened
Unichem Pharmaceuticals USA Inc., of East Brunswick, New Jersey, began a recall on January 21, 2026, of Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, manufactured by Unichem Laboratoris Ltd. in India. The recall was due to the product not meeting the N-Nitroso Bisoprolol impurity specification limits, a cGMP deviation.
The FDA added the recall to its Enforcement Report and classified it on January 30, 2026, with distribution nationwide in the US and PR.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 29300-187-01
- Lot code
- GBHL24005A
Recall details
- Company began the recall
- Sold in
US Nationwide and PR.
- Company
- Unichem Pharmaceuticals USA Inc.East Brunswick, New Jersey
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98323
- Recall number
- D-0301-2026
All recalls from Unichem Pharmaceuticals USA Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
