Sterile Cannabidiol — Class II drug recall D-1328-2020
Terminated recall by BIOTA Biosciences LLC, reported 2020-07-01, distributed nationwide. Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabid
| Recall number | D-1328-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BIOTA Biosciences LLC, Seattle, WA, United States |
| Recall initiated | 2020-05-11 |
| Classified | 2020-06-19 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2020-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | NZ |
| Reason classes | sterility, unapproved product |
| Lot numbers | 1010019P, 101019P, 10102019P |
| Expiration dates | 2021-10-10 |
Product
Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
Reason for recall
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
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-1328-2020. 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.