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D-0103-2025Class II

AvKARE

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
AvKARE
Product type
Drug
Status
Ongoing
Report date
2024-12-11
Distribution
Nationwide within the United States
Firm state
TN
Product quantity
40 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

Labeling: Label Mix-Up

Product description

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28

Code / lot info

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

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →