MethylPREDNISolone Tablets — Class II drug recall D-1449-2019

Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2019-06-26, distributed nationwide. CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Recall number	`D-1449-2019`
Product type	Drug
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States
Recall initiated	2019-05-06
Classified	2019-07-01
Reported by FDA	2019-06-26
Terminated	2021-09-16
Distributed	Nationwide (US)
Reason classes	cgmp
NDC	`68382-0916`, `68382-0916-01`, `68382-0916-05`, `68382-0916-34`, `68382-0917`, `68382-0917-01`, `68382-0917-05`, `68382-0917-11`, `68382-0917-30`, `68382-0917-77`, `68382-0918`, `68382-0918-01`, `68382-0918-05`, `68382-0918-18`, `68382-0918-30`, `68382-0918-77`, `68382-0919`, `68382-0919-01`, `68382-0919-05`, `68382-0919-11`, `68382-0919-30`, `68382-0919-77`
Lot numbers	`FEB-20`, `JUL-20`, `JUN-20`, `M800150`, `M803930`, `M806006`, `M806007`, `M806008`, `M806009`, `M806010`, `M806011`, `M807299`, `M807300`, `M807301`, `M807302`, `M807303`, `M807304`, `M807305`, `M807306`, `M807307`, `M807308`, `M807779`, `M807780`, `M808194`, `M808195`, `M808196`, `M808197`, `M808198`, `M811092`, `M811093`, `M811094`, `M811097`, `M811665`, `M811666`, `M811667`, `M813781`, `M816286`, `M816288`, `M816289`, `M816290` and 19 more

Product

MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34

Reason for recall

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1449-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.