The Recall Desk
ModerateFDA (Drugs)·D-0423-2021·Announced 2021-06-02

Cardinal Health Recalls Oseltamivir Phosphate Oral Suspension Due to Temperature Excursions

Cardinal Health is recalling 15,885 bottles of Oseltamivir Phosphate for Oral Suspension due to intermittent temperature excursions during storage.

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 and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 15,885 bottles of Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL bottles. The product is distributed by Alvogen, Inc. and carries the NDC 47781-384-26. The recall is limited to units with code 484241.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. This condition may affect the stability and quality of the medication.

The affected product was distributed in Florida, Georgia, and South Carolina. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.

The recalled product

Product
OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION (OSELTAMIVIR PHOSPHATE)
Brand
OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION
Affected units
15,885

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)

  • 484241

UPCs (1)

  • 0347781384265

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health 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 198 products in this recall →