Medications & Supplements/Prescription Drugs

Watson Diagnostics Inc.: Capsule Defects: Split or broken capsules

Agency Publication Date: October 29, 2003

Summary

Watson Diagnostics Inc. is recalling approximately 3,352 bottles of Mexiletine Hydrochloride Capsules (150 mg), a prescription medication used to treat certain types of serious irregular heartbeats. The recall was initiated because some capsules may be split or broken, which can affect the delivery of the medication. Affected products were distributed nationwide in 100-count bottles under the Watson Laboratories, Inc. label.

Risk

A split or broken capsule can lead to an incorrect dose of medication being delivered to the patient, potentially reducing the drug's effectiveness in controlling heart rhythm or causing unintended side effects.

What You Should Do

Check your prescription bottle to see if it is Mexiletine Hydrochloride Capsules (150 mg) with NDC 0591-0491-01 and the Watson Laboratories, Inc. label.
Inspect the capsules inside the bottle for any signs of splitting, cracking, or breakage.
Contact your healthcare provider or pharmacist immediately for guidance if you find damaged capsules or if you have concerns about your medication.
Return any unused product to your pharmacy to receive a refund.
Contact Watson Diagnostics Inc. or the manufacturer for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Mexiletine Hydrochloride Capsules, USP, 150 mg (100 capsule bottles)

Model:

NDC 0591-0491-01

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 27437

Status: Active

Manufacturer: Watson Diagnostics Inc.

Manufactured In: United States

Units Affected: 3,352 bottles

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

Check your prescription bottle to see if it is Mexiletine Hydrochloride Capsules (150 mg) with NDC 0591-0491-01 and the Watson Laboratories, Inc. label.

Inspect the capsules inside the bottle for any signs of splitting, cracking, or breakage.

Contact your healthcare provider or pharmacist immediately for guidance if you find damaged capsules or if you have concerns about your medication.

Return any unused product to your pharmacy to receive a refund.

Contact Watson Diagnostics Inc. or the manufacturer for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.