Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported May 3, 2023
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Marketed Without an Approved NDA/ANDA
The recall
Wellness BioSciences issued this moderate-severity FDA Drug recall — Marketed Without an Approved NDA/ANDA.
- Moderate
- severity level
- Class II
- classification
- May 3, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0541-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0541-2023) was formally reported on May 3, 2023, with the manufacturer initiating the action on April 1, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Wellness BioSciences is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 2000 inhalers.
The documented reason for this recall is: Marketed Without an Approved NDA/ANDA Distribution data in the federal record shows the product reached: Nationwide within the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category — 13,821 drugs & medications recalls on record
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Affected scope
2000 inhalers
Related Recalls
6
5 from same agency
Product description
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Reason for recall
Marketed Without an Approved NDA/ANDA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0541-2023 |
| Date reported | May 3, 2023 |
| Date initiated | April 1, 2022 |
| Recalling firm | Wellness BioSciences |
| Firm location | Houston, TX |
| Affected scope | 2000 inhalers |
| Distribution | Nationwide within the United States |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx. Recalled by Wellness BioSciences. Units affected: 2000 inhalers.
Why was this product recalled? ▼
Marketed Without an Approved NDA/ANDA
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 3, 2023. Severity: Moderate. Recall number: D-0541-2023.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the United States.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0541-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported May 3, 2023.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).