Medications & Supplements/Over-the-Counter

Athlete's Needs Chlorpheniramine Maleate Recalled for Superpotency

Agency Publication Date: October 30, 2024

Summary

BLI International, Inc. is recalling 4,901 cases of Athlete's Needs Chlorpheniramine Maleate 4 mg tablets (24-count bottles) because the medication was found to be superpotent during testing. This means the tablets may contain more of the active ingredient than what is listed on the label. The product was manufactured for Athlete's Needs and distributed to private label customers in Ohio and Missouri.

Risk

Taking medication that is stronger than intended increases the risk of side effects associated with antihistamines, such as extreme drowsiness, dizziness, or confusion.

What You Should Do

The recalled products are 24-count bottles of Athlete's Needs Chlorpheniramine Maleate 4 mg tablets (NDC 53185-277-24).
To identify if your bottle is affected, check the packaging for lot number 24A27724 and an expiration date of 01/31/2027.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Athlete's Needs Chlorpheniramine Maleate 4 mg tablets (24-count bottle)

Variants: 4 mg, Tablet

Lot Numbers:

24A27724 (Exp 01/31/2027)

NDC:

53185-277-24

Manufactured for Athlete's Needs, Novi, MI 48377. Stability failure for assay at 6 months test time-point.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95590

Status: Resolved

Manufacturer: BLI International, Inc.

Sold By: Athlete's Needs

Manufactured In: United States

Units Affected: 4,901 cases/24 count each case

Distributed To: Ohio, Missouri

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled products are 24-count bottles of Athlete's Needs Chlorpheniramine Maleate 4 mg tablets (NDC 53185-277-24).

To identify if your bottle is affected, check the packaging for lot number 24A27724 and an expiration date of 01/31/2027.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.