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Class II · ModerateActive recall

Morphine Sulfate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: AD16615, Exp. Date 07/2025
Where it was soldNationwide within in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byOhm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
Brand nameMORPHINE SULFATE
Generic nameMORPHINE SULFATE
Active ingredient(s)MORPHINE SULFATE
Distributed by / forSun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
NDC63304-452-01
Show the full FDA record
Full product labelMorphine 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
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide within in the USA.
Quantity9840 bottles
Recall initiated2025-02-06
Report date2025-03-12
Recall completed—
Recall numberD-0249-2025
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.