Morphine Sulfate Tablet, Film Coated, Extended Release
FDA Recall NDC 63304-451
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Morphine Sulfate (NDC 63304-451). A significant event, classified as Class II, was initiated on Feb 06, 2025 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Dissolution Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications
Feb 06, 2025
Mar 12, 2025
9840 bottles
Recall Profile & Regulatory Data
Event ID
96242
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within in the USA.
Product Description
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
Batch or Lot Expiration Information
Lot# : AD16615, Exp. Date 07/2025
Affected Packages Involved in this Recall
63304-450-03Product
63304-450-01Product
63304-450-05Product
63304-451-03Product
63304-451-01Product
63304-451-05Product
63304-758-03Product
63304-758-01Product
63304-758-05Product
63304-758-50Product
63304-452-03Product
63304-452-01Product
63304-452-05Product
63304-453-03Product
63304-453-01Product
63304-453-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
