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Recall Observatory FDA recall evidence

Drug product

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.

D-0341-2026

February 13, 2026

Class II

Product summary

Firm
AvKARE
Event
Event 98449
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0341-2026

Official wording

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

Code information: Lot # 49261, Exp: 04/30/27

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification