The Recall Desk
ModerateFDA (Drugs)·D-0782-2023·Announced 2023-06-07

Acyclovir Oral Suspension Recalled for Manufacturing Practice Deviations

Akorn's Acyclovir Oral Suspension is being recalled nationwide due to manufacturing practice deviations. The firm closed and could not complete required stability studies for the medication.

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 recall is classified as FDA Class II, but involves no reported illnesses or injuries. The hazard is precautionary—the firm closed and could not complete required stability studies—rather than a confirmed product defect or contamination. The recall fits the rubric criterion for voluntary precautionary recalls at the Moderate severity level.

Plain-English summary

Akorn, Inc. is recalling all lots of Acyclovir Oral Suspension, 200mg/5mL (prescription only). The medication was distributed nationwide in the United States and Puerto Rico by Akorn Operating Company LLC.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. Akorn ceased operations and could no longer conduct the stability studies required to ensure the product's safety and effectiveness over time.

Patients currently taking this medication should contact their prescribing healthcare provider or pharmacist to discuss the recall and available alternatives.

The recalled product

Product
Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug
Hazard
  • unverified-stability

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

Related recalls

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