RecallRadar

FDA Drug recall D-0145-2021

Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cad…

On 2020-12-23 the FDA classified a Class II recall of Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cad… by Zydus Pharmaceuticals Usa, citing failed Dissolution Specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0145-2021
ClassificationClass II
Statusterminated
Initiated2020-12-03
Published2020-12-23
Last updated2026-09-13 11:52 UTC
CompanyZydus Pharmaceuticals Usa
DistributionUS

Product

Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, 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 Specifications

Identifiers

ndc68382-771-30
ndc68382-771-77
ndc68382-772-30
ndc68382-772-77
code_infoM915744 OCT 2021 M904770 FEB 2021

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0145-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.