Class IIReported 2025-03-12

Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC

Reason for Recall

Failed Dissolution Specifications

Recall Number

D-0249-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-02-06

Reported

2025-03-12

Distribution

Nationwide within in the USA.

Code Info

Lot #: AD16615, Exp. Date 07/2025

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.