AvKARE recalls 12.5 mg Sunitinib Malate Capsules (28-count) due to labeling mix-up. This may cause confusion with similar medications. No action needed per official notice.
“AvKARE Sunitinib Malate Capsules Recall: Label Mix-Up Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32504-avkare-sunitinib-malate-capsules-recall-label-mix-up-hazard. Based on FDA recall #D-0103-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0103-2025%22&limit=1).
AvKARE voluntarily recalled Sunitinib Malate Capsules due to a labeling mix-up hazard, according to the FDA on October 18, 2024. The Food and Drug Administration announced the Class II recall of 40 bottles distributed nationwide.
The recall involves a labeling mix-up with Sunitinib Malate Capsules, 12.5 mg, 28-count bottles manufactured for AvKARE in Pulaski, TN. The FDA classified the recall as Class II.
Context
GovInfoNow's records show AvKARE has had 13 other recalls since March 28, 2024. Recent AvKARE recalls include Amantadine Capsules on February 13, 2026, and Rosuvastatin Tablets on December 31, 2025. Other recent recalls of similar products include Sun Pharmaceutical Perampanel 6mg Tablets (June 17, 2026), American Health Packaging Buprenorphine Tablets (August 19, 2026), and Ajanta Pharma Aripiprazole Tablets (May 27, 2026).
How to tell if you have this one
Check for the product name 'Sunitinib Malate Capsules', strength 12.5 mg, and 28-count bottles. The lot number is 100049371 with an expiration date of 07/31/2026.
Brand
AvKARE
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0103-2025 (October 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0103-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.