Mesalamine extended-release capsules recalled due to dissolution failure
Sun Pharmaceutical is recalling Mesalamine extended-release capsules due to failed dissolution specifications. The affected capsules may not dissolve and release medication properly.
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: This is an FDA Class II recall with no reported illnesses or injuries. The dissolution failure creates a risk of harm—medication ineffectiveness—but no adverse events have been reported. Therefore, the hazard is theoretical without reported injury, placing it at severity level 3 per the rubric.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Mesalamine extended-release capsules, USP 500mg, due to failed dissolution specifications. Approximately 54,960 bottles were distributed nationwide in the United States.
In pharmaceuticals, dissolution refers to how a medication dissolves and releases in the body. The recalled capsules failed to meet the specified dissolution requirements.
The affected product can be identified by NDC number 63304-089-13. Specific lot numbers with expiration dates ranging from April 2024 to September 2024 are included in this recall. The manufacturer has provided detailed lot number information to pharmacies and healthcare providers.
Patients using the recalled product should contact their healthcare provider or pharmacist. Do not stop medication without speaking to your healthcare professional. Return the recalled product to your pharmacy for a replacement.
The recalled product
- Product
- MESALAMINE (MESALAMINE)
- Brand
- MESALAMINE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Gastrointestinal
- Hazard
- dissolution-failure
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 (20)
- Lot #s: MHD0606A
- MHD0612A
- Exp. 04/30/2024
- MHD0613A
- MHD0652A
- MHD0657A
- MHD0672A
- MHD0673A
- Exp. 05/31/2024
- MHD0767A
- MHD0768A
- MHD0769A
- MHD0785A
- MHD0799A
- MHD0800A
- MHD0801A
- Exp. 06/30/2024
- MHD0827A
- MHD0828A
- MHD0875A
UPCs (1)
- 0363304089134
Distribution
Distributed nationwide across the United States.
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