AVKARE Inc. recalls Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc.,
AVKARE recalls Dutasteride Capsules (0.5 mg) due to high impurities that could cause harm. Affected lots expired by Feb 2021. Consumers should contact pharmacy for advice.
Recall notice
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Contact the company & request your remedy
What happened, in plain English
AVKARE is recalling Dutasteride Capsules (0.5 mg) because they contain high levels of impurities that may cause harm. This affects specific lots that expired by February 2021. The recall is for prescription-only medication. Read more at govinfonow.com/recall/37481-avkare-dutasteride-capsules-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/37481-avkare-dutasteride-capsules-recall-impurities-may-cause-harm · Updated October 5, 2026 · FDA enforcement record: FDA #D-0661-2020
Cite this page
“AVKARE Dutasteride Capsules Recall: Impurities May Cause Harm.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37481-avkare-dutasteride-capsules-recall-impurities-may-cause-harm. Based on FDA recall #D-0661-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0661-2020%22&limit=1).
Why it’s dangerous
The capsules contain high levels of impurities that may cause harm. The exact health risk is not specified in the recall notice. This is a medication safety issue for people taking the drug.
Who’s affected
Prescription holders of Dutasteride Capsules (0.5 mg) manufactured by AVKARE Inc. in Pulaski, TN. Those with the specific lots listed are most at risk.
How to tell if you have this one
Check your prescription bottle for the lot numbers: 25246 (expires Feb 2021), 24532 (expires Oct 2020), or 23647 (expires Jun 2020). The product is prescription-only and sold in 30-count units.
- Brand
AVKARE- Category
Drug
What to do — step by step
Check Your Prescription
Look for the lot numbers 25246, 24532, or 23647 on your bottle. If you have these, contact your pharmacy for advice.
Questions people ask
Is this product safe to use?
The recall states the product may contain impurities that could cause harm, but does not specify the exact risk. Consult your pharmacist for advice.
What should I do if I have the recalled product?
Contact your pharmacy for guidance. The recall does not provide a specific remedy like returning the product.
How can I tell if I have the recalled product?
Check the lot numbers on your bottle: 25246 (expires Feb 2021), 24532 (expires Oct 2020), or 23647 (expires Jun 2020).
Contact AVKARE
We’ve drafted a message you can send AVKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0661-2020 — AVKARE AVKARE Hello, I own a AVKARE that is covered by recall D-0661-2020 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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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-0661-2020 (January 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0661-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.