Apace KY Amantadine HCl Capsules Recall: FDA Class II

Why it was recalled

Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg

Product description

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

Lot numbers, UPCs & expiration codes

Lot: 16710, exp 07/2018

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1035-2017
Classification: Class II
Status: Terminated
Recall initiated: Jun 19, 2017
FDA report date: Aug 9, 2017
Quantity: 1,483 cartons
Recall type: Voluntary: Firm initiated
Recalling firm: Apace KY LLC

Original FDA data

Every field from FDA enforcement report D-1035-2017, exactly as published.

Show all FDA fields

City: Fountain Run
State: KY
Status: Terminated
Country: United States
Event ID: 77601
Address: 12954 Fountain Run Rd
Code information: Lot: 16710, exp 07/2018
Postal code: 42133-7914
Report date: Aug 9, 2017
Product type: Drugs
Recall number: D-1035-2017
Classification: Class II
Recalling firm: Apace KY LLC
Product quantity: 1,483 cartons
Termination date: May 4, 2018
Reason for recall: Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: KY
Recall initiation date: Jun 19, 2017
Initial firm notification: E-Mail
Center classification date: Jul 31, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1035-2017, published Aug 9, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Apace KY Amantadine HCl Capsules Recall

Summary