Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1499-2014·Announced 2014-08-06

Teva Recalls Lansoprazole Triple Therapy Blister Packs Due to Impurities

Teva Pharmaceuticals is recalling 89,215 blister packs of triple therapy containing lansoprazole, clarithromycin, and amoxicillin due to failed impurity specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a failure in impurity specifications rather than a high-risk pathogen or structural defect.

Plain-English summary

Teva Pharmaceuticals USA is recalling 89,215 blister packs of triple therapy, which contains lansoprazole delayed-release capsules, clarithromycin tablets, and amoxicillin capsules. The product is distributed nationwide.

The recall is being conducted because stability testing revealed that the lansoprazole component failed to meet impurity specifications. The affected products are identified by specific lot codes and expiration dates ranging from April 2014 to April 2015.

Consumers should stop using the recalled medication and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall is limited to the specific lot numbers and expiration dates listed in the official notice.

The recalled product

Product: 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…
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Antibiotic / Acid Reflux
Hazard: impurities
degradation
Affected units: 89,215

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

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.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · impurities