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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

Morphine Sulfate Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: March 3, 2025
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Summary

Sun Pharmaceutical Industries Inc. is recalling 9,840 bottles of Morphine Sulfate Extended-Release Tablets (100 mg). This recall was initiated because the tablets failed dissolution specifications, meaning the drug may not release into the body as intended. The affected 100-count bottles were distributed nationwide in the United States.

Risk

If the medication fails to dissolve correctly, it may result in the patient not receiving the required dose for pain management or, conversely, could lead to too much medication being released at once, increasing the risk of respiratory depression or overdose.

What You Should Do

  1. The recalled product is Morphine Sulfate Extended-Release Tablets (100 mg, 100-count bottles) labeled with NDC 63304-452-01, Lot AD16615, and an expiration date of 07/2025.
  2. 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 the manufacturer for further instructions.
  3. 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: Morphine Sulfate Extended-Release Tablets (100 mg, 100-count bottles)
Variants: 100 mg, Extended-Release, Tablets
Lot Numbers:
AD16615 (Exp 07/2025)
NDC:
63304-452-01

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: 96242
Status: Active
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 9840 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.