Agency classClass IIOur severity:High FDA (Drugs)·D-0249-2025·Announced 2025-03-12

Morphine Sulfate Tablets Recalled Over Failed Dissolution Specifications

Sun Pharmaceutical is recalling Morphine Sulfate Extended-Release 100 mg tablets (lot AD16615) because they fail dissolution specifications, potentially resulting in unpredictable drug delivery.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II classification with no reported hospitalizations or illnesses in the source. However, failed dissolution specifications on an opioid medication represent a risk-of-harm product where unpredictable drug delivery could result in overdose or therapeutic failure.

Plain-English summary

Sun Pharmaceutical Industries Inc. is recalling Morphine Sulfate Extended-Release Tablets, 100 mg, in 100-count bottles. The recalled product is identified by lot number AD16615 with an expiration date of July 2025. Approximately 9,840 bottles were distributed nationwide within the USA.

The recall is due to failed dissolution specifications. The tablets may not dissolve properly in the body, which could lead to unpredictable absorption and delivery of morphine, potentially resulting in either insufficient pain relief or overdose.

This medication is taken by mouth and is used to treat pain. Patients taking this medication should check their bottles and verify the lot number.

If you have this medication with the recalled lot number, contact your pharmacy or healthcare provider. Do not stop taking your medication without consulting your healthcare provider, as this could affect your pain management.

The recalled product

Product: MORPHINE SULFATE (MORPHINE SULFATE)
Brand: MORPHINE SULFATE
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Category: Drug
Hazard: dissolution-defect
overdose-risk
Affected units: 9,840

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: AD16615
Exp. Date 07/2025

UPCs (5)

0363304453010
0363304758016
0363304452013
0363304450019
0363304451016

Distribution

Distributed nationwide across the United States.

Same brand · MORPHINE SULFATE

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Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC

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