RecallRadar

FDA Drug recall D-0038-2024

Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx…

On 2023-10-11 the FDA classified a Class II recall of Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx… by Zydus Pharmaceuticals Usa, citing failed Dissolution Specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0038-2024
ClassificationClass II
Statusterminated
Initiated2023-09-21
Published2023-10-11
Last updated2026-09-13 11:52 UTC
CompanyZydus Pharmaceuticals Usa
DistributionUS

Product

Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534

Reason

Failed Dissolution Specifications

Identifiers

ndc68382-255-06
ndc68382-255-14
ndc68382-255-16
ndc68382-255-01
ndc68382-255-05
ndc68382-255-30
ndc68382-255-77
ndc68382-256-14
ndc68382-256-01
ndc68382-256-16
ndc68382-256-05
ndc68382-256-30
ndc68382-256-77
ndc68382-256-06
ndc68382-257-14
ndc68382-257-01
ndc68382-257-16
ndc68382-257-05
ndc68382-257-30
ndc68382-257-77
ndc68382-257-06
code_infoLot#: M300652 and M300651, exp. Dec 2024

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-0038-2024%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.