The Recall Desk
ModerateFDA (Drugs)·D-1449-2019·Announced 2019-06-26

Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination

Zydus Pharmaceuticals is recalling Methylprednisolone tablets due to cross-contamination caused by cleaning failures. The affected lots are distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a manufacturing deviation (cross-contamination) rather than a known high-risk pathogen or structural defect.

Plain-English summary

Zydus Pharmaceuticals USA Inc. is recalling Methylprednisolone Tablets, USP 4 mg, 21 Tablets dosepack, Rx Only. The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving cross-contamination with other products resulting from a cleaning failure.

The affected product is distributed nationwide in the USA. Specific lot numbers and expiration dates are listed in the recall documentation, ranging from February 2020 to March 2021.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for a refund or replacement.

The recalled product

Product
METHYLPREDNISOLONE (METHYLPREDNISOLONE)
Brand
METHYLPREDNISOLONE

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Zydus Pharmaceuticals USA Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →