CLASS II Drug recall · Reported 1 Jul 2020 · FDA Enforcement Report

Sterile Cannabidiol (CBD) 50mg/mL recalled by BIOTA Biosciences

Biota Biosciences is recalling Sterile Cannabidiol (CBD) 50mg/mL, distributed nationwide in the US. The recall was initiated on 11 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 101019P, 1010019P,10102019P, Exp. Date 10/10/2021
Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1328-2020
FDA event ID
85706
Recalling firm
Biota Biosciences, Seattle, WA
Classification
Class II
Status
Terminated
Recall initiated
11 May 2020
FDA classified
19 Jun 2020
Reported
1 Jul 2020
Type
Voluntary: Firm initiated
Customers notified by
E-Mail

Timeline

11 May 2020Recall initiated by company
19 Jun 2020Classified by FDA+39 days
1 Jul 2020Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin

Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.

Product as listed by the FDA

Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial

Where it was distributed

Nationwide within the United States and New Zealand

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin

Which lots are affected?

Lot #: 101019P, 1010019P,10102019P, Exp. Date 10/10/2021

Where was it sold?

Nationwide within the United States and New Zealand

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 85706

This product is part of a recall event; the main page for the event is Sterile Cannabidiol (CBD) + Curcumin 50mg/mL recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IISterile Cannabidiol (CBD) + Curcumin 50mg/mL recalledBiota BiosciencesHidden Drug IngredientsNationwide
CLASS IISterile Curcumin 50mg/mL recalled by BIOTA BiosciencesBiota BiosciencesHidden Drug IngredientsNationwide
CLASS IISterile Curcumin, 4mg/mL recalled by BIOTA BiosciencesBiota BiosciencesHidden Drug IngredientsNationwide
CLASS IISterile Cannabidiol (CBD) 4mg/mL recalled by BIOTA BiosciencesBiota BiosciencesHidden Drug IngredientsNationwide

More recalls from Biota Biosciences

All 5
ReportedClassRecallCompanyReasonWhere
DrugCLASS IISterile Cannabidiol (CBD) 4mg/mL recalled by BIOTA BiosciencesBiota BiosciencesHidden Drug IngredientsNationwide
DrugCLASS IISterile Curcumin, 4mg/mL recalled by BIOTA BiosciencesBiota BiosciencesHidden Drug IngredientsNationwide
DrugCLASS IISterile Curcumin 50mg/mL recalled by BIOTA BiosciencesBiota BiosciencesHidden Drug IngredientsNationwide
DrugCLASS IISterile Cannabidiol (CBD) + Curcumin 50mg/mL recalledBiota BiosciencesHidden Drug IngredientsNationwide

Other Cannabidiol (cbd recalls

All 2
ReportedClassRecallCompanyReasonWhere
DrugCLASS IISterile Cannabidiol (CBD) 4mg/mL recalled by BIOTA BiosciencesBiota BiosciencesHidden Drug IngredientsNationwide