FDA recall D-0249-2025

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 for recall

Failed Dissolution Specifications

Distribution

Nationwide within in the USA.

Key facts

Status

Ongoing

Initiation date

2025-02-06

Report date

2025-03-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0249-2025