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.
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
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.
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.
People prescribed amantadine by a doctor who received this specific product lot. Those with conditions requiring this medication are most at risk.
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.
Verify the product name, lot number 49261, and expiration date 04/30/27 on the packaging.
The recall was initiated due to an out of specification finding in dissolution tests.
The official notice does not specify a remedy, so contact AvKARE directly for guidance.
The recall indicates the product may not work as intended, but the official notice does not state it is unsafe in normal use.
We’ve drafted a message you can send AvKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0341-2026 — AvKARE AvKARE Hello, I own a AvKARE 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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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.
