Why it was recalled
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # GBHL24005A, Exp Date: 09/2026
Where it was sold
US Nationwide and PR.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0301-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 21, 2026
- FDA report date
- Feb 11, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unichem Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-0301-2026, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98323
- Address
- 1 Tower Center Blvd Ste 2200
- Code information
- Lot # GBHL24005A, Exp Date: 09/2026
- Postal code
- 08816-1145
- Report date
- Feb 11, 2026
- Product type
- Drugs
- Recall number
- D-0301-2026
- Classification
- Class II
- Recalling firm
- Unichem Pharmaceuticals USA Inc.
- Reason for recall
- cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US Nationwide and PR.
- Recall initiation date
- Jan 21, 2026
- Initial firm notification
- Letter
- Center classification date
- Jan 30, 2026