CLASS II ONGOING Drug recall · Reported 3 May 2023 · FDA Enforcement Report
CBD Metered Dose Inhaler (CBD) 5 mg Dose recalled
Wellness BioSciences is recalling CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, distributed nationwide in the US. The recall was initiated on 1 Apr 2022 and the FDA has classified it as Class II.
Check your package
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-0541-2023
- FDA event ID
- 92089
- Recalling firm
- Wellness BioSciences, Houston, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Apr 2022
- FDA classified
- 21 Apr 2023
- Reported
- 3 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Drug class
- Inhalers & Asthma Medication
Timeline
| 1 Apr 2022 | Recall initiated by company | |
| 21 Apr 2023 | Classified by FDA | +385 days |
| 3 May 2023 | Published 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
Marketed Without an Approved NDA/ANDA
Product as listed by the FDA
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Where it was distributed
Nationwide within the United States
Questions about this recall
Is CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays recalled?
Yes. Wellness BioSciences recalled CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays on 1 Apr 2022. The recall is Class II and its status is Ongoing. Recall number D-0541-2023.
Why was it recalled?
Marketed Without an Approved NDA/ANDA
Which lots are affected?
All lots
Where was it sold?
Nationwide within the United States
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.