CLASS II Drug recall · Reported 6 Aug 2014 · FDA Enforcement Report

triple therapy, Lansoprazole DR Capsules USP 30mg recalled

Teva Pharmaceuticals U is recalling triple therapy, Lansoprazole DR Capsules USP 30mg, Clarithromycin Tablets USP 500mg, distributed nationwide in the US. The recall was initiated on 1 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes35427772A, 35427773A, 35427774A, 35427916A, 35428048A, 35428051A, Exp. 04/14; 35428127A, 35428218A, Exp. 07/14; 35429573A, 35429574A, 35429575A, Exp. 02/15; 35429697A, Exp. 03/15; 35430184A, Exp. 04/15.

Quantity recalled89,215 blister pack

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-1499-2014
FDA event ID: 67882
Recalling firm: Teva Pharmaceuticals U, Horsham, PA
Classification: Class II
Status: Terminated
Recall initiated: 1 Apr 2014
FDA classified: 31 Jul 2014
Reported: 6 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Antibiotics

Timeline

1 Apr 2014	Recall initiated by company
31 Jul 2014	Classified by FDA	+121 days
6 Aug 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.

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

triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78

Where it was distributed

Nationwide

Questions about this recall

Is triple therapy, Lansoprazole DR Capsules USP 30mg, Clarithromycin Tablets USP 500mg recalled?

Yes. Teva Pharmaceuticals U recalled triple therapy, Lansoprazole DR Capsules USP 30mg, Clarithromycin Tablets USP 500mg on 1 Apr 2014. The recall is Class II and its status is Terminated. Recall number D-1499-2014.

Why was it recalled?

Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.

Which lots are affected?

35427772A, 35427773A, 35427774A, 35427916A, 35428048A, 35428051A, Exp. 04/14; 35428127A, 35428218A, Exp. 07/14; 35429573A, 35429574A, 35429575A, Exp. 02/15; 35429697A, Exp. 03/15; 35430184A, Exp. 04/15.

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 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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