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.
Labeling: Label Mix-Up
AvKARE is recalling 12.5 mg Sunitinib Malate Capsules (28-count bottles) because of a labeling mix-up. This could lead to confusion with similar medications, but no action is required as per the official recall notice.
The labeling mix-up means the capsules might be confused with other medications. This could lead to incorrect use if someone mistakes them for a different drug, but it does not cause physical harm directly.
People with a prescription for Sunitinib Malate Capsules (12.5 mg, 28-count) from AvKARE in Pulaski, TN. Those most at risk are patients using the medication as prescribed.
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.
Verify the product name, strength, and count on your bottle to confirm it matches the recalled items.
No action is needed per the official recall notice.
The expiration date is 07/31/2026.
Check for the product name 'Sunitinib Malate Capsules', strength 12.5 mg, and 28-count bottles with lot number 100049371.
We’ve drafted a message you can send AvKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0103-2025 — AvKARE AvKARE Hello, I own a AvKARE that is covered by recall D-0103-2025 from AvKARE. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
