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Drug FDA Class II Terminated Sub/super-potent

Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

BLI International, Inc. Published Nov 6, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 45/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact BLI International, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Superpotent Drug: Stability failure for assay at 6 months test time-point.

Hazards

Superpotency · primary

Affected products (1)

Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

CHLORPHENIRAMINE MALEATE 4MG · 4,901 cases/24 count each case

NDC: 53185-277, 53185-277-24
Lot codes: 24A27724
Code info: Lot # 24A27724, Exp 01/31/2027

Affected areas

MissouriOhio

Timeline

  1. Initiated
    Oct 21, 2024
  2. Published
    Nov 6, 2024
  3. Terminated
    Dec 5, 2025
Recall number
D-0029-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.