FDA DrugsClass II
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-co...
Published: February 11, 2026Recall ID: D-0301-2026Category: drugsCountry: US
Reason for Recall / Hazard
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | East Brunswick |
| State | NJ |
| Openfda › Nui › 1 | N0000175359 |
| Openfda › Nui › 2 | N0000175419 |
| Openfda › Nui › 3 | M0471776 |
| Openfda › Unii › 1 | UR59KN573L |
| Openfda › Unii › 2 | 0J48LPH2TH |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 854908 |
| Openfda › Rxcui › 2 | 854916 |
| Openfda › Rxcui › 3 | 854919 |
| Openfda › Spl id | 057844aa-5d7e-4e83-b71f-9072d2a2b93d |
| Openfda › Brand name | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
| Openfda › Spl set id | b9ee689a-ea12-435d-b01c-70d45891e62f |
| Openfda › Package ndc › 1 | 29300-187-13 |
| Openfda › Package ndc › 2 | 29300-187-01 |
| Openfda › Package ndc › 3 | 29300-187-05 |
| Openfda › Package ndc › 4 | 29300-187-10 |
| Openfda › Package ndc › 5 | 29300-188-13 |
| Openfda › Package ndc › 6 | 29300-188-01 |
| Openfda › Package ndc › 7 | 29300-188-05 |
| Openfda › Package ndc › 8 | 29300-188-10 |
| Openfda › Package ndc › 9 | 29300-189-13 |
| Openfda › Package ndc › 10 | 29300-189-01 |
| Openfda › Package ndc › 11 | 29300-189-05 |
| Openfda › Package ndc › 12 | 29300-189-10 |
| Openfda › Product ndc › 1 | 29300-187 |
| Openfda › Product ndc › 2 | 29300-188 |
| Openfda › Product ndc › 3 | 29300-189 |
| Openfda › Generic name | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Thiazides [CS] |
| Openfda › Pharm class pe | Increased Diuresis [PE] |
| Openfda › Substance name › 1 | BISOPROLOL FUMARATE |
| Openfda › Substance name › 2 | HYDROCHLOROTHIAZIDE |
| Openfda › Pharm class epc | Thiazide Diuretic [EPC] |
| Openfda › Manufacturer name | Unichem Pharmaceuticals (USA), Inc. |
| Openfda › Application number | ANDA079106 |
| Openfda › Is original packager | true |
| Event id | 98323 |
| Address 1 | 1 Tower Center Blvd Ste 2200 |
| Address 2 | N/A |
| Code info | Lot # GBHL24005A, Exp Date: 09/2026 |
| Postal code | 08816-1145 |
| Report date | 20260211 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260121 |
| Initial firm notification | Letter |
| Center classification date | 20260130 |
Overview
- Recalling FirmUnichem Pharmaceuticals USA Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide and PR.