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Amantadine HCl Capsules 100 mg
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DRUG RECALLMODERATE

Amantadine HCl Capsules 100 mg

AvKARE is recalling Amantadine HCl Capsules 100 mg (NDC 50268-069-15) nationwide due to failed dissolution specifications.

What to do

Do not use this medication without consulting your healthcare provider or pharmacist. Contact your pharmacy or AvKARE at www.avkare.com to verify if your prescription is affected and to obtain a replacement.

Recalled
Listed
Updated
Recall No.
D-0341-2026
Agency
FDA
Firm
AvKARE
Recall ID
98449
Status
ONGOING

Why it was recalled

AvKARE is recalling Amantadine HCl Capsules, 100 mg, 50-count unit dose packages (NDC 50268-069-15) distributed nationwide due to failed dissolution specifications. The affected capsules may not dissolve properly, potentially affecting drug bioavailability. Patients should contact their healthcare provider or pharmacist before discontinuing the medication.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Amantadine HCl, Capsules, UPS

Strength
100 mg
NDC / UPC
NDC 50268-069-15

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification