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Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by ...

FDA Recall #D-0036-2025 — Class II — October 22, 2024

Recall #D-0036-2025 Date: October 22, 2024 Classification: Class II Status: Ongoing

Product Description

Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.

Reason for Recall

Failed Impurities/Degradation Specification

Recalling Firm

Dr. Reddy's Laboratories, Inc. — Princeton, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2,040 100-count bottles

Distribution

Nationwide in the USA

Code Information

Lot# FG14062, Exp 10/31/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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