Medications & Supplements/Prescription Drugs

Dr. Reddy's Morphine Sulfate Extended-Release Tablets Recalled for Impurities

Agency Publication Date: November 4, 2024

Summary

Dr. Reddy's Laboratories, Inc. is recalling 2,572 bottles of Morphine Sulfate Extended-Release Tablets (15 mg and 30 mg) because the medication failed to meet quality specifications for impurities and degradation. This recall affects 100-count bottles manufactured by Mayne Pharma and distributed nationwide. If you are taking this medication, you should consult your healthcare provider or pharmacist for guidance.

Risk

The presence of impurities or degradation products means the medication may not be as effective as intended or could contain chemical breakdowns that pose a moderate health risk. No incidents or injuries have been reported to date.

What You Should Do

The recalled products are 100-count bottles of Morphine Sulfate Extended-Release Tablets in 15 mg and 30 mg strengths distributed by Dr. Reddy's Laboratories, Inc. and manufactured by Mayne Pharma.
Check your medication bottle for the following identifiers: 15 mg tablets with NDC 51862-185-01 and Lot FG14062 (Exp 10/31/2025), or 30 mg tablets with NDC 51862-186-01 and Lot FG13996 (Exp 09/30/2025).
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.
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:

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: Morphine Sulfate Extended-Release Tablets (15 mg)

Variants: 15 mg, 100-count per bottle, Rx Only

Lot Numbers:

FG14062 (Exp 10/31/2025)

NDC:

51862-185-01

Manufactured by Mayne Pharma, Greenville, NC 27834; Recall #: D-0036-2025

Product: Morphine Sulfate Extended-Release Tablets (30 mg)

Variants: 30 mg, 100-count per bottle, Rx Only

Lot Numbers:

FG13996 (Exp 09/30/2025)

NDC:

51862-186-01

Manufactured by Mayne Pharma, Greenville, NC 27834; Recall #: D-0037-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95588

Status: Active

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (2,040 100-count bottles; 532 100-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

The recalled products are 100-count bottles of Morphine Sulfate Extended-Release Tablets in 15 mg and 30 mg strengths distributed by Dr. Reddy's Laboratories, Inc. and manufactured by Mayne Pharma.

Check your medication bottle for the following identifiers: 15 mg tablets with NDC 51862-185-01 and Lot FG14062 (Exp 10/31/2025), or 30 mg tablets with NDC 51862-186-01 and Lot FG13996 (Exp 09/30/2025).

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.

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:

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: Morphine Sulfate Extended-Release Tablets (15 mg)

Variants: 15 mg, 100-count per bottle, Rx Only

Lot Numbers:

FG14062 (Exp 10/31/2025)

NDC:

51862-185-01

Manufactured by Mayne Pharma, Greenville, NC 27834; Recall #: D-0036-2025

Product: Morphine Sulfate Extended-Release Tablets (30 mg)

Variants: 30 mg, 100-count per bottle, Rx Only

Lot Numbers:

FG13996 (Exp 09/30/2025)

NDC:

51862-186-01

Manufactured by Mayne Pharma, Greenville, NC 27834; Recall #: D-0037-2025