Recalling firm
AvKARE
Product type
Drug
Status
Ongoing
Report date
2026-03-04
Distribution
Nationwide in the USA.
Firm state
TN
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Product description
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.
Code / lot info
Lot # 49261, Exp: 04/30/27
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.