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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

Methoxsalen Capsules Recalled for Failed Dissolution Specifications

Agency Publication Date: January 24, 2024
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Summary

Strides Pharma Inc. has recalled 396 50-count bottles of Methoxsalen Capsules, USP 10mg (methoxsalen) because the medication failed to meet required dissolution standards. This defect means the capsules may not dissolve correctly in the body, which could prevent the drug from working as intended or cause inconsistent levels of the medication in the bloodstream. These prescription capsules were distributed nationwide in the USA to pharmacies and other distributors. If you have this medication, you should consult your doctor or pharmacist about your treatment.

Risk

Failed dissolution means the medication may not release properly after ingestion, potentially leading to ineffective treatment of the patient's condition. No injuries or adverse incidents have been reported in connection with this recall.

What You Should Do

  1. This recall affects 50-count bottles of Methoxsalen Capsules, USP 10mg, a prescription medication used to treat certain skin conditions.
  2. Check your medication packaging for NDC 64380-752-16 and lot number 7253092B with an expiration date of 09/30/2025.
  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 Strides Pharma Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

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: Methoxsalen Capsules, USP 10mg (50-count bottle)
Variants: 10mg, Capsule
Lot Numbers:
7253092B (Exp 09/30/2025)
NDC:
64380-752-16

Recall #: D-0260-2024; Manufactured by Strides Pharma Science Ltd. in Bengaluru, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93703
Status: Resolved
Manufacturer: Strides Pharma Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 396 50-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 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.