CLASS II Drug recall · Reported 18 Nov 2020 · FDA Enforcement Report

Mesalamine Delayed-Release Tablets recalled by Teva Pharmaceuticals U

Teva Pharmaceuticals USA is recalling Mesalamine Delayed-Release Tablets, USP per, distributed nationwide in the US. The recall was initiated on 28 Oct 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s: 1342498A, Exp. 12/2020; 1342499A, Exp. 01/2021; 1354638A, Exp. 03/2021; 1354639A, 1358274A, 1358448A, 1364618A, 1369884A, Exp. 05/2021; 1366195A, 1369885A, 1373570A, Exp. 06/2021; 1373571A, Exp. 07/2021; 1388571A, Exp. 01/2022; 1395725A, 1396585A, 1397550A, 1399389A, Exp. 04/2022; 1403885A, 1403886A, Exp. 06/2022.

NDC0591-2245

UPC0305912245229

Quantity recalled133,829 bottles

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-0069-2021
FDA event ID: 86667
Recalling firm: Teva Pharmaceuticals USA, Parsippany, NJ
Brand: Mesalamine
Manufacturer: Actavis Pharma, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 28 Oct 2020
FDA classified: 6 Nov 2020
Reported: 18 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

28 Oct 2020	Recall initiated by company
6 Nov 2020	Classified by FDA	+9 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: Out-of-specification dissolution results were obtained 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 tablets per 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 U.S. and PR

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.

Which lots are affected?

Lot #s: 1342498A, Exp. 12/2020; 1342499A, Exp. 01/2021; 1354638A, Exp. 03/2021; 1354639A, 1358274A, 1358448A, 1364618A, 1369884A, Exp. 05/2021; 1366195A, 1369885A, 1373570A, Exp. 06/2021; 1373571A, Exp. 07/2021; 1388571A, Exp. 01/2022; 1395725A, 1396585A, 1397550A, 1399389A, Exp. 04/2022; 1403885A, 1403886A, Exp. 06/2022.

Where was it sold?

Nationwide in the U.S. and PR

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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Other Mesalamine recalls

All 9

Reported	Class	Recall	Company	Reason	Where
6 Mar 2024Drug	CLASS II	Mesalamine Extended-Release Capsules, USP 500mg recalledMesalamine	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
31 Jan 2024Drug	CLASS II	Mesalamine Delayed-Release Tablets, USP per tablet recalledMesalamine	SUN Pharmaceutical Industries	Sterility	Nationwide
18 Nov 2020Drug	CLASS II	Mesalamine Delayed-Release Tablets, USP (Once-Daily) recalled by AVKARE	Avkare	Potency & Assay	Nationwide
11 Mar 2020Drug	CLASS II	Mesalamine Delayed-Release Tablets recalled by Teva Pharmaceuticals UMesalamine	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
25 Jan 2017Drug	CLASS III	Pentasa (mesalamine) Controlled-Release Capsules, 250 mg recalledPentasa	Shire	Other	Nationwide