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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

TraMADol HCl 50 mg Tablets Recalled for Foreign Baclofen Tablet

Agency Publication Date: September 30, 2024
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Summary

RemedyRepack Inc. is recalling 23,970 tablets of TraMADol HCl (tramadol hydrochloride) 50 mg after a pharmacist reported finding a tablet of baclofen, a muscle relaxant, inside a 1,000-count bottle of tramadol. These pain medications were repackaged into smaller blister packs of 30, 90, and 180 counts and distributed across the country. If you have this medication, you should check your packaging for the specific lot numbers involved.

Risk

Taking the wrong medication can lead to unintended side effects or leave the intended condition untreated. Accidental ingestion of baclofen instead of tramadol poses a risk of adverse reactions or complications from improper drug use.

What You Should Do

  1. This recall affects TraMADol HCl 50 mg tablets repackaged by RemedyRepack Inc. and sold in 30-count blister packs (NDC 70518-3824-00), 90-count blister packs (NDC 70518-3824-02), and 180-count blister packs (NDC 70518-3824-03).
  2. Identify if your product is affected by looking for lot numbers J0732085-101023, B2546618-100523, or B2546541-100523 on the blister pack label.
  3. 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 RemedyRepack Inc. at 724-465-8762 for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: TraMADol HCl 50 mg Tabletby RemedyRepack Inc.
Variants: 30-count blister pack, 90-count blister pack, 180-count blister pack, 50 mg, Tablet
Lot Numbers:
J0732085-101023
B2546618-100523
B2546541-100523
NDC:
70518-3824-00
70518-3824-02
70518-3824-03

Manufactured by Advagen Pharma Limited; repackaged by RemedyRepack Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94567
Status: Resolved
Manufacturer: RemedyRepack Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 23,970 Tablets
Distributed To: Nationwide

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 ยท 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.