CLASS II Drug recall · Reported 18 Nov 2020 · FDA Enforcement Report
Mesalamine Delayed-Release Tablets, USP (Once-Daily) recalled by AVKARE
Avkare is recalling Mesalamine Delayed-Release Tablets, USP (Once-Daily), distributed nationwide in the US. The recall was initiated on 30 Oct 2020 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-0070-2021
- FDA event ID
- 86695
- Recalling firm
- Avkare, Pulaski, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Oct 2020
- FDA classified
- 6 Nov 2020
- Reported
- 18 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 30 Oct 2020 | Recall initiated by company | |
| 6 Nov 2020 | Classified by FDA | +7 days |
| 18 Nov 2020 | 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
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 Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lots: 26085 Exp. 07/2021, 26426 Exp. 01/2022, 26983 Exp. 04/2022, 28647 Exp. 06/2022
Where was it sold?
Nationwide
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 26 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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|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
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| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
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Other Mesalamine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mesalamine Extended-Release Capsules, USP 500mg recalledMesalamine | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| 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 USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Mesalamine Delayed-Release Tablets recalled by Teva Pharmaceuticals UMesalamine | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Pentasa (mesalamine) Controlled-Release Capsules, 250 mg recalledPentasa | Shire | Other | Nationwide |