FDAClass IINovember 13, 2024

Morphine Sulfate Extended-Release Tablets 30 mg recall: Impurity Out of Spec

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

Why was Morphine Sulfate Extended-Release Tablets 30 mg recalled?

Failed Impurities/Degradation Specification

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# FG13996, Exp 09/30/2025

Product
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
532 100-count bottles
Distribution
Nationwide in the USA
Recall date
November 13, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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