NDC 68382-918

methylprednisolone 16 mg tablet

Where it's made

Factory	Where	Role	Last FDA inspection
Zydus Lifesciences Limited	Ahmedabad, India	Makes it and tests it	Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action

May 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots: Lots: M800144, M800145, EXP, Feb-20; M808193, EXP Jun-20; M811096, EXPJul-20
May 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots: Lots: M800150 Feb-20; M803930, M806006, M806007, M806008, M806009, M806010, M806011, EXP Mar-20; M807299, M807300, M807301, M807302, M807303, M807304, M807305, M807306, M807307, M807308, EXP May-20; M807779, M807780, M808194, M808195, M808196, M808197, M808198, EXP Jun-20; M811092, M811093, M811094…
May 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots: lots: M713034, M713035, M713036, EXP Nov-19; M814747 Sep-20; M819266, EXP Dec-20
May 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots: Lots: M713043, M713047, EXP Dec-19; M713045, EXP Nov- 19; M816143, EXP Oct-20.
May 6, 2019 · Class II · Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lots: Lots: M713224, M713225, M713226, EXP Nov-19; M814746 EXP Sep-20; M816148 EXP Oct-20; M901600, M901601 EXP Feb-21

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Methylprednisolone: every company that makes it
Form: tablet, oral
Strength: 16 mg
Approval: ANDA ANDA206751
On the market since: May 1, 2018
Package NDCs: 68382-918-01 68382-918-05 68382-918-18 68382-918-30 68382-918-77
Official label: DailyMed (National Library of Medicine), updated Nov 10, 2025

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