Apace KY recalls Amantadine capsules due to label mix-up with cyclobenzaprine
Apace KY LLC recalls 50-capsule amantadine HCl units sold in TN with cyclobenzaprine tablets inside. Label mix-up risks incorrect medication use.
Lower-risk 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
Contact the company
What happened, in plain English
Apace KY LLC is recalling amantadine HCl capsules that contain cyclobenzaprine tablets instead of the intended medication. This mix-up could lead to taking the wrong drug, which may cause serious health issues. Read more at govinfonow.com/recall/41551-apace-ky-recalls-amantadine-capsules-due-to-label-mix-up.
Source Summary by GovInfoNow · govinfonow.com/recall/41551-apace-ky-recalls-amantadine-capsules-due-to-label-mix-up · Updated October 8, 2026 · FDA enforcement record: FDA #D-1035-2017
Cite this page
“Apace KY recalls Amantadine capsules due to label mix-up with cyclobenzaprine.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41551-apace-ky-recalls-amantadine-capsules-due-to-label-mix-up. Based on FDA recall #D-1035-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1035-2017%22&limit=1).
Why it’s dangerous
The cartons labeled as amantadine capsules contain blister packs of cyclobenzaprine tablets. This mix-up means users might take cyclobenzaprine instead of amantadine, which could cause unintended side effects or health issues.
Who’s affected
Prescription holders of amantadine HCl capsules with cyclobenzaprine tablets inside. People who took these capsules without knowing the mix-up are at risk.
How to tell if you have this one
Check for unit dose cartons labeled 'Amantadine HCl 100 mg Capsules' from Apace KY LLC, manufactured for AvKARE Inc in Pulaski, TN. The NDC code 50268-0069-15 and lot number 16710 (expiring 07/2018) are specific identifiers.
- Brand
Apace KY- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
KY
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1035-2017 | 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: 16710, exp 07/2018 | 1,483 cartons |
| D-1036-2017 | Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15; Lot: 16710, exp 07/2018 | N/A |
What to do — step by step
Check Product Label
Look for cartons labeled 'Amantadine HCl 100 mg Capsules' with cyclobenzaprine tablets inside.
Where it went and when
Where it was distributed
Distributed in Kentucky.
FDA distribution: “KY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Kentucky.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1035-2017 (June 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1035-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.