Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville,
Summary
The FDA issued a Class II for Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Ma by Dr. Reddy's Laboratories, Inc.. Reason: Failed Impurities/Degradation Specification.
Details
Source
Drug Recall
External ID
D-0037-2025
Action Date
2024-11-13
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot# FG13996, Exp 09/30/2025
Quantity Affected: 532 100-count bottles
Reason for Recall
Failed Impurities/Degradation Specification
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-22
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 35 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dr. Reddy's Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dr. Reddy's Laboratories, Inc. have FDA actions?
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0037-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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