← FDA ENFORCEMENT
D-0029-2025Class II
BLI International, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
BLI International, Inc.
Product type
Drug
Status
Terminated
Report date
2024-11-06
Distribution
Product was shipped to two private label customers ( OH & MO) as a final packaged product.
Firm state
NY
Product quantity
4,901 cases/24 count each case
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Product description
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Code / lot info
Lot # 24A27724, Exp 01/31/2027
Other recalls SPEQ maps to Validation & Qualification
2026-10-21Class IIZydus Pharmaceuticals (USA) Inc2026-10-21Class IIIMagellan Diagnostics, Inc.2026-10-21Class IIMicrogenics Corporation2026-10-14Class IICipla USA, Inc.
See all Validation & Qualification recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →