Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported March 6, 2024
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
Failed Dissolution Specifications: Out of specification for dissolution.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Sun Pharmaceutical Industries INC recalled Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufa… - a moderate-severity action.
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufa… was recalled by Sun Pharmaceutical Industries INC in March 6, 2024. Reason: Failed Dissolution Specifications: Out of specification for dissolution.. Check the official notice for the remedy. Verify recall #D-0350-2024 with the FDA Drug before acting.
The recall
Sun Pharmaceutical Industries INC issued this moderate-severity FDA Drug recall-Failed Dissolution Specifications: Out of specification for dissolution..
- Moderate
- severity level
- Class II
- classification
- March 6, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0350-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0350-2024) was formally reported on March 6, 2024, with the manufacturer initiating the action on February 5, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Sun Pharmaceutical Industries INC is listed as the recalling firm, operating out of Princeton, NJ. Federal records list the affected scope as 54,960 bottles.
The documented reason for this recall is: Failed Dissolution Specifications: Out of specification for dissolution. Distribution data in the federal record shows the product reached: Nationwide in the U.S.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
54,960 bottles
Related Recalls
6
5 from same agency
Product description
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
Reason for recall
Failed Dissolution Specifications: Out of specification for dissolution.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0350-2024 |
| Date reported | March 6, 2024 |
| Date initiated | February 5, 2024 |
| Recalling firm | Sun Pharmaceutical Industries INC |
| Firm location | Princeton, NJ |
| Affected scope | 54,960 bottles |
| Distribution | Nationwide in the U.S. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0350-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.. Recalled by Sun Pharmaceutical Industries INC. Units affected: 54,960 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out of specification for dissolution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 6, 2024. Severity: Moderate. Recall number: D-0350-2024.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the U.S..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0350-2024) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 6, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.