Teva Pharmaceuticals USA Inc recalls Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc.,
Teva recalls 12.5 mg Sunitinib Malate capsules due to moisture content exceeding specifications. This may affect product stability and safety for patients requiring this medication.
Lower-risk recall
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Contact the company & request your remedy
What happened, in plain English
Teva is recalling 12.5 mg Sunit: 28-count bottles that may have moisture content above approved levels. This could affect the medication's stability and safety for patients using it. Read more at govinfonow.com/recall/33391-teva-sunitinib-malate-capsules-recall-moisture-content-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33391-teva-sunitinib-malate-capsules-recall-moisture-content-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0913-2023
Cite this page
“Teva Sunitinib Malate Capsules Recall: Moisture Content Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33391-teva-sunitinib-malate-capsules-recall-moisture-content-risk. Based on FDA recall #D-0913-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0913-2023%22&limit=1).
Why it’s dangerous
The capsules may contain more moisture than approved, which could affect the medication's stability. This might lead to reduced effectiveness or potential safety issues for patients using the drug.
Who’s affected
Patients prescribed Sunitinib Malate capsules by a doctor. Those with the specific lot number (100037220) and expiration date (10/2024) are most at risk.
How to tell if you have this one
Check for the product name 'Sunitinib Malate Capsules', 12.5 mg, 28-count bottles. Look for lot number 100037220 and expiration date 10/2024 on the packaging.
- Brand
Teva- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number (100037220) and expiration date (10/2024) on the packaging.
Questions people ask
Is this product safe to use?
The recall is due to moisture content exceeding specifications, which may affect stability and safety. Patients should contact their doctor for guidance.
What should I do if I have this product?
The recall does not specify a remedy, so check with your doctor or pharmacist for advice.
How can I tell if I have the recalled product?
Look for the lot number 100037220 and expiration date 10/2024 on the 12.5 mg Sunitinib Malate capsules packaging.
Contact Teva
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0913-2023 — Teva Teva Hello, I own a Teva that is covered by recall D-0913-2023 from Teva. 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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Where this comes from
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-0913-2023 (July 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0913-2023 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.