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FDAFDA · Food and drugs·Recall number D-0249-2025

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

Published March 12, 2025 · Recall initiated: February 6, 2025

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Failed Dissolution Specifications

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
MORPHINE SULFATE
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Distributor
Nationwide within in the USA.
UPC
0363304453010
Lot
Lot #: AD16615, Exp. Date 07/2025
Risk classification
Class II
Area (FDA)
drug
Country
United States

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