Recalls / Class II

Class IID-0036-2025

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.

Affected lot / code info

Lot# FG14062, Exp 10/31/2025

Why it was recalled

Failed Impurities/Degradation Specification

Recalling firm

Firm

Dr. Reddy's Laboratories, Inc.

Notification channel

N/A

Type

Voluntary: Firm initiated

Address

107 College Rd E, N/A, Princeton, New Jersey 08540-6623

Distribution

Quantity

2,040 100-count bottles

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-10-22

FDA classified

2024-11-04

Posted by FDA

2024-11-13

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0036-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.