Morphine Sulfate Extended-Release Tablets Recalled for Impurities and Degradation
Dr. Reddy's Laboratories is recalling Morphine Sulfate Extended-Release Tablets 15 mg nationwide due to failed impurity and degradation specifications. Patients taking affected lots should contact their healthcare provider immediately.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a prescription opioid medication where the product failed impurity and degradation specification testing. No illnesses or injuries have been reported. This meets the criterion for a risk-of-harm product where injury has not yet been reported, warranting a High severity designation.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Morphine Sulfate Extended-Release Tablets 15 mg, 100-count bottles due to failure to meet impurity and degradation specifications.
The tablets failed specification testing for impurities and degradation. These specifications ensure the chemical integrity and safety of the medication, and failure to meet them could compromise product quality.
The recall affects 2,040 bottles nationwide. The affected lot is FG14062 with expiration date 10/31/2025, NDC 51862-185-01.
Patients currently using this medication should not stop taking it without medical guidance. Contact your pharmacy or prescribing healthcare provider immediately with your prescription to confirm whether your medication is from the recalled lot. Your healthcare provider will determine the best course of action, which may include an alternative opioid medication.
The recalled product
- Product
- Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Opioid
- Hazard
- chemical-impurity
- product-degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# FG14062
- Exp 10/31/2025
Distribution
Distributed nationwide across the United States.
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