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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 2,000
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 hazard · unapproved drug
See all →- CriticalBuy-Herbal Recalls Kian Pee Wan Capsules for Undeclared Drug Ingredients
FDA (Drugs) · 2026-08-19
- SevereMR. 7 Super capsules recalled as Class I over undeclared sildenafil
FDA (Drugs) · 2026-03-11
- SevereMojo Max Fusion capsules recalled as Class I over undeclared drug ingredients
FDA (Drugs) · 2026-03-11
- SevereSilintan herbal pills recalled as Class I for undeclared meloxicam
FDA (Drugs) · 2026-03-11
- SevereAgebox iKids-Growth Day Formula Capsules Recalled Over Undeclared Drug Ingredient
FDA (Drugs) · 2026-03-04
Similar recalls
- ModerateBasic Reset CBD Product Recalled for Lack of FDA Approval
FDA (Drugs) · 2019-11-13
- SevereBiota Biosciences Recalls Sterile Cannabidiol Vials Due to Sterility Concerns
FDA (Drugs) · 2020-07-01
- SevereBIOTA Biosciences Recalls Sterile Cannabidiol Vials for Sterility Concerns
FDA (Drugs) · 2020-07-01
- ModerateBasic Reset CBD Oil Recalled for Lack of FDA Approval
FDA (Drugs) · 2019-11-13
- SevereBIOTA Biosciences Recalls Sterile Cannabidiol and Curcumin Vials
FDA (Drugs) · 2020-07-01
- SevereB Complex Injection Recalled for Lack of FDA Approval
FDA (Drugs) · 2014-08-13