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.
What this means for you
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
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.
Related recalls
Same brand · MORPHINE SULFATE
- LowMorphine sulfate oral solution recalled due to carton label size mismatch
FDA (Drugs) · 2025-12-17
- SevereMorphine Sulfate Injection Recalled Due to Defective Vials
FDA (Drugs) · 2021-10-06
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27