Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Methylphenidate Tablets Recalled for Metal Contamination

Agency Publication Date: July 24, 2023

Summary

Sun Pharmaceutical Industries Inc. is recalling 7,313 bottles of Methylphenidate Hydrochloride Tablets, USP 20mg (generic Ritalin), after a foreign metal substance was found embedded in a tablet. These prescription tablets were sold in 100-count bottles and are used to treat ADHD and narcolepsy. No injuries or incidents have been reported in connection with this recall.

Risk

Ingesting a tablet with embedded metal fragments can cause physical injury to the mouth, throat, or digestive system.

What You Should Do

This recall affects Methylphenidate Hydrochloride Tablets, USP 20mg, sold in 100-count bottles (NDC 57664-230-88) under lot number AC74459 with an expiration date of 07/31/2024.
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 Sun Pharmaceutical Industries Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 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: Methylphenidate Hydrochloride Tablets, USP 20mg (100-count bottle)

Variants: 20mg, Tablet

Lot Numbers:

AC74459 (Exp 07/31/2024)

NDC:

57664-230-88

Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92680

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 7313 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 Methylphenidate Hydrochloride Tablets, USP 20mg, sold in 100-count bottles (NDC 57664-230-88) under lot number AC74459 with an expiration date of 07/31/2024.

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 Sun Pharmaceutical Industries Inc. for further instructions.

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