Chlorpheniramine Maleate 4 mg tablets — Class II drug recall D-0029-2025
Terminated recall by BLI International, Inc., reported 2024-11-06, distributed in MO, OH. Superpotent Drug: Stability failure for assay at 6 months test time-point.
| Recall number | D-0029-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BLI International, Inc., Deer Park, NY, United States |
| Recall initiated | 2024-10-21 |
| Classified | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| Terminated | 2025-12-05 |
| Distributed | MO, OH |
| Quantity | 4,901 cases |
| Reason classes | potency, specification failure |
| NDC | 53185-0277, 53185-0277-24 |
| Lot numbers | 24A27724 |
| Expiration dates | 2027-01-31 |
Product
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Reason for recall
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0029-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.