Bisoprolol Fumarate tablets — Class II drug recall D-0010-2018
Terminated recall by Unichem Pharmaceuticals Usa Inc, reported 2017-10-25, distributed nationwide. Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during
| Recall number | D-0010-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unichem Pharmaceuticals Usa Inc, Hasbrouck Heights, NJ, United States |
| Recall initiated | 2017-10-02 |
| Classified | 2017-10-18 |
| Reported by FDA | 2017-10-25 |
| Terminated | 2018-09-13 |
| Distributed | Nationwide (US) |
| Quantity | 96,876 bottles |
| Reason classes | specification failure |
| NDC | 29300-0126, 29300-0126-01, 29300-0126-05, 29300-0126-13, 29300-0127, 29300-0127-01, 29300-0127-05, 29300-0127-13 |
| Lot numbers | GBOL16001, GBOL16002, GBOL16015 |
| Expiration dates | 2017-12-31, 2018-03-31 |
Product
Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13.
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
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-0010-2018. 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.