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Class II · ModerateActive recall

Amantadine Hcl

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # 49261, Exp: 04/30/27
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAvPAK
Brand nameAMANTADINE HCL
Generic nameAMANTADINE HYDROCHLORIDE
Active ingredient(s)AMANTADINE HYDROCHLORIDE
Distributed by / forAvKARE, Pulaski, TN 38478, www.avkare.com
NDC50268-069-15
Show the full FDA record
Full product labelAmantadine 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.
Recalling firmAvKARE
DistributionNationwide in the USA.
QuantityN/A
Recall initiated2026-02-13
Report date2026-03-04
Recall completed—
Recall numberD-0341-2026
ClassificationClass II
FDA statusOngoing
Origin on filePulaski TN United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.