The Recall Desk
HighFDA (Drugs)·D-0103-2025·Announced 2024-12-11

Prescription Drug Sunitinib Malate Subject to Label Mix-Up Recall

AvKARE is recalling 40 bottles of Sunitinib Malate Capsules due to a label mix-up. The affected lot was distributed nationwide in the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This recall meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported'—a prescription drug with a labeling mix-up presents potential for patient harm, though no illnesses or injuries are explicitly reported in the source.

Plain-English summary

AvKARE is recalling 40 bottles of Sunitinib Malate Capsules, 12.5 mg, due to a labeling mix-up. The recall affects Lot #100049371 with an expiration date of July 31, 2026, identified by NDC 42291-901-28.

The affected bottles were distributed nationwide within the United States.

Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance. Healthcare providers and pharmacists should identify and quarantine affected stock from Lot #100049371 and verify that patients have received correct medication.

The recalled product

Product
SUNITINIB MALATE (SUNITINIB MALATE)
Brand
SUNITINIB MALATE
Manufacturer
AvKARE
Category
Drug
Hazard
  • label-mix-up

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 (2)

  • Lot #: 100049371
  • Exp. Date 07/31/2026

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · SUNITINIB MALATE

Same category