Recall: D-0249-2025

Class II - Potentially Harmful

Class IIClassification

2025-02-06Initiated

OngoingStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

Product

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

Reason

Failed Dissolution Specifications

Distribution

Nationwide within in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.