Lower risk Drug recall · FDA · Published February 13, 2026

AvKARE Amantadine Capsules Recall: Failed Dissolution Specifications

AvKARE recalls 100 mg amantadine capsules due to failed dissolution specifications. This affects certain lots manufactured in Pulaski, TN. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0341-2026Drug AvKARE ›

Lower-risk recall

Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.

Take action

Contact the company

Official pagewww.avkare.com

Recalling firmAvKARE615 N 1st St · Pulaski, TN 38478-2403

✎ GovInfoNow plain-language explainer

AvKARE is recalling specific amantadine capsules because they failed dissolution tests. This means the medication may not work as intended, which could affect treatment effectiveness. Read more at govinfonow.com/recall/31482-avkare-amantadine-capsules-recall-failed-dissolution-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/31482-avkare-amantadine-capsules-recall-failed-dissolution-specifications · Updated August 17, 2026 · FDA enforcement record: FDA #D-0341-2026

Cite this page

“AvKARE Amantadine Capsules Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31482-avkare-amantadine-capsules-recall-failed-dissolution-specifications. Based on FDA recall #D-0341-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0341-2026%22&limit=1).

AvKARE voluntarily recalled Amantadine HCl capsules due to failed dissolution specifications, the FDA said on Feb. 13, 2026. The Class II recall affects products distributed nationwide.

How to tell if you have it

Brand: AvKARE
Product: Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose
NDC: 50268-069-15
Lot #: 49261
Expiration: 04/30/27

The hazard

The recall was initiated due to an out-of-specification finding in dissolution, according to the FDA.

Context

GovInfoNow's records show AvKARE has 13 other recalls on record since March 28, 2024. Other recent recalls of similar products include Harvard Drug Group Memantine Capsules Recall (March 24, 2026), Supernus Trokendi XR 50mg Capsules Failed Dissolution Specifications Recall (Aug. 31, 2026), and Sun Pharmaceutical Lisdexamfetamine Capsules Recall (Oct. 28, 2025).

How to tell if you have this one

Check for the product name 'Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only'. Look for the lot number 49261 and expiration date 04/30/27 on the packaging.

Brand
AvKARE
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name, lot number 49261, and expiration date 04/30/27 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 19 days after the firm started it.

Feb 13, 2026Firm started the recall
Feb 23, 2026FDA classified it Class II
Mar 4, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Take action

Contact AvKARE

We’ve drafted a message you can send AvKARE to request your refund or repair — edit it as you like.

✉️ Open in emailCompany site

Subject: Recall D-0341-2026 — AvKARE Amantadine Capsules Recall: Failed Dissolution Specifications

Hello,

I own a AvKARE Amantadine Capsules Recall: Failed Dissolution Specifications that is covered by recall D-0341-2026 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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Link to this recall

<a href="https://govinfonow.com/recall/31482-avkare-amantadine-capsules-recall-failed-dissolution-specifications">AvKARE Amantadine Capsules Recall: Failed Dissolution Specifications (GovInfoNow)</a>

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-0341-2026 (February 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0341-2026 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.