Amantadine HCl Capsules (Apace KY) – label mix-up (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
Brand
Apace KY LLC
Lot Codes / Batch Numbers
Lot: 16710, exp 07/2018
Products Sold
Lot: 16710, exp 07/2018
Apace KY LLC is recalling Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured f due to Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
KY
Page updated: Jan 7, 2026