FDA-Drug2026-03-04Class IIPROCESSING DEFECT
AvKARE Amantadine HCl 100 mg capsules recalled for failed dissolution
What this means
AvKARE is recalling one lot of Amantadine HCl 100 mg capsules because they failed to meet dissolution specifications—meaning the capsules may not break down properly in the body, affecting how much medicine you receive. This is a quality issue identified during manufacturing testing. No injuries have been reported.
- Check if your Amantadine HCl matches: AvKARE brand, 100 mg capsules, Lot #49261, expiration 04/30/27
- Stop taking this medication if you have this lot
- Contact your pharmacist or doctor for a replacement or alternative
- Do not throw away the capsules; ask your pharmacist how to safely dispose of them
The agency's original wording
Hazard
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA.
Affected count
N/A
Manufactured in
615 N 1st St, N/A, Pulaski, TN, United States
Products
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0341-2026Want us to check the next one for you?
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