FDA Drugs recall ·
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle… recall
- Recall number
- D-0029-2025
- Date
- (initiated October 21, 2024)
- Company / brand
- BLI International, Inc.
75 N Industry Ct, Deer Park, NY, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 4,901 cases/24 count each case
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Why was it recalled?
Superpotent Drug: Stability failure for assay at 6 months test time-point.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 24A27724, Exp 01/31/2027
Distribution
Product was shipped to two private label customers ( OH & MO) as a final packaged product.
States: Missouri
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0029-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.