Clobazam Oral Suspension — Class II drug recall D-1519-2019
Terminated recall by Bionpharma Inc., reported 2019-07-31, distributed nationwide. Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests
| Recall number | D-1519-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bionpharma Inc., Princeton, NJ, United States |
| Recall initiated | 2019-07-16 |
| Classified | 2019-07-25 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2020-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 3,020 bottles |
| Reason classes | microbial contamination, sterility |
| NDC | 69452-0116, 69452-0116-45 |
| Lot numbers | 18246 |
| Expiration dates | 2020-09 |
Product
Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45.
Reason for recall
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
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-1519-2019. 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.