CLASS II Drug recall · Reported 11 Mar 2020 · FDA Enforcement Report
Mesalamine Delayed-Release Tablets recalled by Teva Pharmaceuticals U
Teva Pharmaceuticals U is recalling Mesalamine Delayed-Release Tablets, USP, distributed nationwide in the US. The recall was initiated on 20 Feb 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-0862-2020
- FDA event ID
- 85017
- Recalling firm
- Teva Pharmaceuticals U, Parsippany, NJ
- Brand
- Mesalamine
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Feb 2020
- FDA classified
- 2 Mar 2020
- Reported
- 11 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 20 Feb 2020 | Recall initiated by company | |
| 2 Mar 2020 | Classified by FDA | +11 days |
| 11 Mar 2020 | Published in enforcement report | +9 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: Low out of specification dissolution result observed during stability testing.
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, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Is Mesalamine Delayed-Release Tablets, USP recalled?
Yes. Teva Pharmaceuticals U recalled Mesalamine Delayed-Release Tablets, USP on 20 Feb 2020. The recall is Class II and its status is Terminated. Recall number D-0862-2020.
Why was it recalled?
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Which lots are affected?
Lot #: 1342500A, Exp 10/2020
Where was it sold?
Nationwide in the USA.
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.
More recalls from Teva Pharmaceuticals U
All 196| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxylamine Succinate and Pyridoxine Hydrochloride recalledDoxylamine Succinate And Pyridoxine Hydrochloride | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | Nationwide |
| Drug | CLASS II | Brinzolamide Ophthalmic Suspension recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Packaging Defects | Nationwide |
Other Mesalamine recalls
All 6| 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 U | Potency & Assay | Nationwide |
| Drug | CLASS II | Mesalamine Delayed-Release Tablets, USP (Once-Daily) recalled by AVKARE | AVKARE | Potency & Assay | Nationwide |
| Drug | CLASS III | Pentasa (mesalamine) Controlled-Release Capsules, 250 mg recalledPentasa | Shire | Other | Nationwide |