AvKARE 2024-12-11 Health serious FDA
Health · FDA · Recall #FDA-D-0103-2025
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE,… Recall
Issued December 11, 2024 · AvKARE
In December 2024, AvKARE recalled the Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Labeling: Label Mix-Up
What you should do
- 1 Stop using Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact AvKARE to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- AvKARE
- Category
- Health
- Recall date
- December 11, 2024
- Units affected
- Not reported
- Sold at
- Nationwide within the United States
- Recall number
- FDA-D-0103-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- AvKARE has 10 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.