RecallRadar

FDA Drug recall D-0853-2022

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Dist…

On 2022-05-11 the FDA classified a Class II recall of Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Dist… by Dr Reddy S Laboratories, citing failed Dissolution Specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0853-2022
ClassificationClass II
Statusterminated
Initiated2022-04-15
Published2022-05-11
Last updated2026-09-13 11:52 UTC
CompanyDr Reddy S Laboratories
DistributionOH

Product

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.

Reason

Failed Dissolution Specifications

Identifiers

ndc43598-560-79
ndc43598-560-78
ndc43598-561-79
ndc43598-561-78
code_infoLot #: T2000645, Exp 07/2022

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-0853-2022%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.