Medications & Supplements/Prescription Drugs

Advagen Pharma Tramadol Hydrochloride Tablets Recalled for Foreign Tablets

Agency Publication Date: May 7, 2024

Summary

Advagen Pharma Limited is recalling Tramadol Hydrochloride (traMADol Hydrochloride) Tablets, USP 50 mg, which are sold in 1000-count bottles. This recall was initiated after a pharmacist discovered a tablet of baclofen, a muscle relaxant, inside a bottle labeled as tramadol. Approximately 2,592 bottles are affected by this recall.

Risk

Taking an incorrect medication like baclofen instead of the prescribed tramadol can lead to unintended side effects or lack of proper treatment for the patient's condition. If you believe you have taken the wrong medication, contact your healthcare provider or pharmacist immediately.

What You Should Do

This recall affects 1000-count bottles of Tramadol Hydrochloride Tablets, USP 50 mg, distributed by Advagen Pharma Limited and manufactured by Rubicon Research Private Limited.
Identify affected bottles by looking for NDC 72888-080-00 and Lot number 230774Hl with an expiration date of 4/30/2026 on the label.
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 Advagen Pharma Limited for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

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: traMADol Hydrochloride Tablets, USP (1000-count bottle)by Advagen Pharma Limited

Variants: 50 mg, Tablet

Lot Numbers:

230774Hl (Exp 4/30/2026)

NDC:

72888-080-00

Distributed by Advagen Pharma Limited; Manufactured by Rubicon Research Private Limited.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94467

Status: Active

Manufacturer: Rubicon Research Private Limited

Sold By: Pharmacies

Manufactured In: India

Units Affected: 2,592 1000-count Bottles

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 · 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

This recall affects 1000-count bottles of Tramadol Hydrochloride Tablets, USP 50 mg, distributed by Advagen Pharma Limited and manufactured by Rubicon Research Private Limited.

Identify affected bottles by looking for NDC 72888-080-00 and Lot number 230774Hl with an expiration date of 4/30/2026 on the label.

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 Advagen Pharma Limited for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.