The Recall Desk
ModerateFDA (Drugs)·D-0366-2024·Announced 2024-03-13

Methylprednisolone Acetate Injectable Suspension Recalled for Failed Dissolution

Eugia US LLC recalls methylprednisolone acetate injection due to failed dissolution specifications. Affected states: Ohio, Tennessee, Louisiana, and Mississippi.

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: This is a FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing quality defect affecting drug dissolution specifications, primarily an efficacy concern rather than an immediate safety threat.

Plain-English summary

Eugia US LLC is recalling methylprednisolone acetate injectable suspension, USP 400mg per 5mL vials due to failed dissolution specifications. The recalled product is a prescription steroid injection used for intra-articular, intralesional, intramuscular, or soft tissue injection.

The affected lots are 3MA23001, 3MA23002, and 3MA23003, with expiration date of 3/31/2025. Approximately 10,080 vials were distributed to Ohio, Tennessee, Louisiana, and Mississippi.

Consumers and healthcare providers should discontinue use of affected lots and contact Eugia US LLC or their healthcare provider for guidance on replacement product.

The recalled product

Product
METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE ACETATE)
Brand
METHYLPREDNISOLONE ACETATE
Manufacturer
Eugia US LLC
Hazard
  • dissolution-defect
  • manufacturing-defect

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 (4)

  • Lot #: 3MA23001
  • 3MA23002
  • 3MA23003
  • Exp 3/31/2025

UPCs (2)

  • 0355150313013
  • 0355150314010

Distribution

Distributed in 4 states:

  • LA
  • MS
  • OH
  • TN

Same brand · METHYLPREDNISOLONE ACETATE