AVKARE Inc. recalls Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN
AVKARE recalls 100 mg Amantadine HCl Capsules (NDC 50268-069-15) due to failed dissolution specifications. This may affect medication effectiveness. Check your product details to determine if you are affected.
Lower-risk recall
Failed Dissolution Specifications
Contact the company & request your remedy
What happened, in plain English
AVKARE is recalling 100 mg Amantadine HCl Capsules (50 capsules per bottle) because they failed dissolution specifications. This could mean the medication doesn't work as intended, so affected users should contact their doctor or pharmacist. Read more at govinfonow.com/recall/40707-avkare-amantadine-capsules-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/40707-avkare-amantadine-capsules-recall-failed-dissolution-specifications · Updated October 7, 2026 · FDA enforcement record: FDA #D-0633-2018
Cite this page
“AVKARE Amantadine Capsules Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40707-avkare-amantadine-capsules-recall-failed-dissolution-specifications. Based on FDA recall #D-0633-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0633-2018%22&limit=1).
Why it’s dangerous
The capsules failed dissolution specifications, meaning they may not release the medication properly in the body. This could lead to the medication not working as intended, potentially affecting treatment effectiveness for conditions like Parkinson's disease or influenza.
Who’s affected
People who have the specific Amantadine HCl Capsules (100 mg, 50 capsules) manufactured by AVKARE Inc. in Pulaski, TN with NDC 50268-069-15 and lot number 16719 (expiring July 2018) are affected. Those using prescription medication for conditions like Parkinson's disease or influenza are most at risk.
How to tell if you have this one
Check for the product name 'Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only' with NDC 50268-069-15 and lot number 16719 (expiring July 2018). This product was manufactured by AVKARE Inc. in Pulaski, TN.
- Brand
AVKARE- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 50268-069-15 and lot number 16719 on the product packaging.
Contact Your Doctor
Talk to your healthcare provider about whether the recalled product is part of your treatment plan.
Questions people ask
Is this product safe to use?
The recall is due to failed dissolution specifications, which may affect medication effectiveness. It is not safe to use if you have the specific product details listed in the recall.
How can I tell if I have the recalled product?
Check for the NDC code 50268-069-15 and lot number 16719 on the product packaging. This product was manufactured by AVKARE Inc. in Pulaski, TN.
What should I do if I have the recalled product?
Contact your doctor or pharmacist to discuss whether you need a different medication. The recall does not require immediate disposal.
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-0633-2018 — AVKARE AVKARE Hello, I own a AVKARE that is covered by recall D-0633-2018 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-0633-2018 (March 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0633-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.