Lansoprazole Triple Therapy (Teva) – impurity concern (2014)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78
Brand
Teva Pharmaceuticals USA
Lot Codes / Batch Numbers
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.
Products Sold
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.
Teva Pharmaceuticals USA is recalling triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Cap due to Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026