October 2024 FDA Recall Chlorpheniramine Maleate 4mg by Bli International, Inc.
D-0029-2025 - Superpotent Drug

This Class II drug recall was voluntarily initiated by Bli International, Inc. on October 21, 2024 for the product Chlorpheniramine Maleate 4mg. The FDA reported the reason for recall as superpotent drug. The product was distributed in Product was shipped to two private label customers ( OH & MO) as a final packaged product. and the recall is currently terminated.

Recall Number: D-0029-2025

Reason for Recall
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Initiated
10-21-2024
Reported
11-06-2024
Quantity
4,901 cases/24 count each case

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95590
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
BLI International, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was shipped to two private label customers ( OH & MO) as a final packaged product.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-05-2025
Product Description About Product Description
Full technical description of the product.
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

Batch or Lot Expiration Information

Lot# 24A27724, Exp 01/31/2027

Affected Packages Involved in this Recall

53185-277-24 Chlorpheniramine Maleate 4mg