Recall archive / FDA drug enforcement
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-... — FDA record D-0029-2025
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 21, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
- Reason
- Superpotent Drug: Stability failure for assay at 6 months test time-point.
- Classification
- Class II
- Recalling firm
- BLI International, Inc.
- Quantity
- 4,901 cases/24 count each case
- Agency-reported status
- Terminated
- Source record identifier
- D-0029-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # 24A27724, Exp 01/31/2027 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was shipped to two private label customers ( OH & MO) as a final packaged product.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 6, 2024
- Recall initiation date
- Oct 21, 2024
- Center classification date
- Oct 30, 2024
- Termination date
- Dec 5, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.