Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by May...

FDA Drug Recall #D-0037-2025 — Class II — October 22, 2024

Recall Summary

Recall Number D-0037-2025
Classification Class II — Moderate risk
Date Initiated October 22, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Dr. Reddy's Laboratories, Inc.
Location Princeton, NJ
Product Type Drugs
Quantity 532 100-count bottles

Product Description

Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.

Reason for Recall

Failed Impurities/Degradation Specification

Distribution Pattern

Nationwide in the USA

Lot / Code Information

Lot# FG13996, Exp 09/30/2025

Other Recalls from Dr. Reddy's Laboratories, Inc.

Recall # Classification Product Date
D-0219-2026 Class III Varenicline Tablets, 1mg, 56 Tablets, Rx only, ... Nov 11, 2025
D-0008-2026 Class II Succinylcholine Chloride Injection, USP, 200 mg... Sep 26, 2025
D-0525-2025 Class II Omeprazole Delayed-release Capsules, USP, 20mg,... Jun 30, 2025
D-0365-2025 Class I Levetiracetam 0.75% in Sodium Chloride Injectio... Mar 13, 2025
D-0117-2025 Class III Javygtor (sapropterin dihydrochloride) Tablets ... Nov 22, 2024

Frequently Asked Questions

Nitrosamines are probable human carcinogens — they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.