CLASS II ONGOING Drug recall · Reported 6 Mar 2024 · FDA Enforcement Report
Mesalamine Extended-Release Capsules, USP 500mg recalled
Sun Pharmaceutical Industries is recalling Mesalamine Extended-Release Capsules, USP 500mg, distributed nationwide in the US. The recall was initiated on 5 Feb 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0350-2024
- FDA event ID
- 93909
- Recalling firm
- Sun Pharmaceutical Industries, Princeton, NJ
- Brand
- Mesalamine
- Manufacturer
- Sun Pharmaceutical Industries Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Feb 2024
- FDA classified
- 23 Feb 2024
- Reported
- 6 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 5 Feb 2024 | Recall initiated by company | |
| 23 Feb 2024 | Classified by FDA | +18 days |
| 6 Mar 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Out of specification for dissolution.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Is Mesalamine Extended-Release Capsules, USP 500mg recalled?
Yes. Sun Pharmaceutical Industries recalled Mesalamine Extended-Release Capsules, USP 500mg on 5 Feb 2024. The recall is Class II and its status is Ongoing. Recall number D-0350-2024.
Why was it recalled?
Failed Dissolution Specifications: Out of specification for dissolution.
Which lots are affected?
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, MHD0876A, MHD0898A, MHD0901A, Exp. 07/31/2024; MHD1081A, MHD1082A, MHD1087A Exp. 09/30/2024.
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Mesalamine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mesalamine Delayed-Release Tablets, USP per tablet recalledMesalamine | Sun Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Mesalamine Delayed-Release Tablets recalled by Teva Pharmaceuticals UMesalamine | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Mesalamine Delayed-Release Tablets, USP (Once-Daily) recalled by AVKARE | AVKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Mesalamine Delayed-Release Tablets recalled by Teva Pharmaceuticals UMesalamine | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Pentasa (mesalamine) Controlled-Release Capsules, 250 mg recalledPentasa | Shire | Other | Nationwide |