Bisoprolol Fumarate and Hydrochlorothiazide tablets — Class II drug recall D-0301-2026
Ongoing recall by Unichem Pharmaceuticals USA Inc., reported 2026-02-11, distributed nationwide. cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
| Recall number | D-0301-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unichem Pharmaceuticals USA Inc., East Brunswick, NJ, United States |
| Recall initiated | 2026-01-21 |
| Classified | 2026-01-30 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 29300-0187, 29300-0187-01, 29300-0187-05, 29300-0187-10, 29300-0187-13, 29300-0188, 29300-0188-01, 29300-0188-05, 29300-0188-10, 29300-0188-13, 29300-0189, 29300-0189-01, 29300-0189-05, 29300-0189-10, 29300-0189-13 |
| Lot numbers | GBHL24005A |
| Expiration dates | 2026-09 |
Product
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
Reason for recall
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0301-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.