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Drug FDA Class II Ongoing Failed specifications

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

SUN PHARMACEUTICAL INDUSTRIES INC Published Mar 12, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact SUN PHARMACEUTICAL INDUSTRIES INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications

Hazards

Failed Dissolution · primary

Affected products (1)

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

MORPHINE SULFATE · 9840 bottles

NDC: 63304-450, 63304-451, 63304-758, 63304-452, 63304-453, 63304-450-03, 63304-450-01, 63304-450-05, 63304-451-03, 63304-451-01, 63304-451-05, 63304-758-03, 63304-758-01, 63304-758-05, 63304-758-50, 63304-452-03, 63304-452-01, 63304-452-05, 63304-453-03, 63304-453-01, 63304-453-05
Code info: Lot #: AD16615, Exp. Date 07/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 6, 2025
  2. Published
    Mar 12, 2025
Recall number
D-0249-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.