Recall: D-0074-2021

Class II - Potentially Harmful

Class IIClassification

2020-10-27Initiated

TerminatedStatus

Zydus Pharmaceuticals (USA) InFirm

Product

Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77

Reason

Failed Dissolution Specification

Distribution

Distributed Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.