Wellness BioSciences recalls CBD metered dose inhalers marketed without FDA approval. All units are affected. Consumers should check product details and contact the company for guidance.
Marketed Without an Approved NDA/ANDA
Wellness BioSciences has recalled all CBD metered dose inhalers (5 mg dose, 1 inhaler, 100 sprays) because they were marketed without FDA approval. This means the product is not legally approved for sale in the U.S. and may not be safe or effective.
The product was marketed without an FDA-approved drug application (NDA/ANDA), meaning it lacks safety and efficacy testing. This could lead to health risks if used without proper oversight.
Anyone who purchased Wellness BioSciences CBD inhalers. People using these products for medical purposes without FDA approval may be at risk.
Check for the product name 'CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays' from Wellness BioSciences Rx. All lots are affected.
Look for the product name and lot number on the inhaler packaging.
The recall states the product was marketed without FDA approval, so it may not be safe or effective. Wellness BioSciences does not provide specific safety details.
The recall record does not mention refunds or replacements. Contact Wellness BioSciences directly for assistance.
Yes, all lots of this product are affected by the recall.
We’ve drafted a message you can send Wellness BioSciences to request your refund or repair — edit it as you like.
Subject: Recall D-0541-2023 — Wellness BioSciences Wellness BioSciences Hello, I own a Wellness BioSciences that is covered by recall D-0541-2023 from Wellness BioSciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
