Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
- Agency
- FDA Drug
- Recall date
- Jan 21, 2026
- Status
- Ongoing
- Company
- Unichem Pharmaceuticals USA Inc.
1. What product was recalled?
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2
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
Quantity: N/A
Code or lot text: Lot # GBHL24005A, Exp Date: 09/2026
- LOT
- Exp Date: 09/2026
- LOT
- Lot # GBHL24005A
- NDC
- 29300-187
- NDC
- 29300-187-01
- NDC
- 29300-187-05
- NDC
- 29300-187-10
- NDC
- 29300-187-13
- NDC
- 29300-188
- NDC
- 29300-188-01
- NDC
- 29300-188-05
- NDC
- 29300-188-10
- NDC
- 29300-188-13
- NDC
- 29300-189
- NDC
- 29300-189-01
- NDC
- 29300-189-05
- NDC
- 29300-189-10
- NDC
- 29300-189-13
- RECALL-NUMBER
- D-0301-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
View source evidence for state distribution
- Puerto Rico: US Nationwide and PR.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Drug source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.