The Recall Desk
ModerateFDA (Drugs)·D-0541-2023·Announced 2023-05-03

CBD Metered Dose Inhaler Recalled for Marketing Without FDA Approval

Wellness BioSciences is recalling its CBD Metered Dose Inhaler nationwide because it was marketed without an approved NDA/ANDA.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory non-compliance—marketing a drug product without FDA approval—which constitutes a precautionary recall. Without evidence of actual harm, the severity is classified as Moderate per the rubric for recalls with no reported illness or injury.

Plain-English summary

Wellness BioSciences is recalling all lots of its CBD Metered Dose Inhaler (5 mg per dose, 100 metered sprays per inhaler) because the product was marketed without an FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Approximately 2000 units were distributed nationwide within the United States. No drug product may be legally sold without an approved NDA or ANDA. This product should not have been marketed.

Consumers who have purchased this product should not use it. Consult your healthcare provider if you have questions about your health or if you have used this product. Return the product to the place of purchase or contact Wellness BioSciences for return and refund instructions.

The recalled product

Product
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Manufacturer
Wellness BioSciences
Category
Drug — CBD / Inhalation
Hazard
  • unapproved-drug

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.

Related recalls

Same category