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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

AVKARE Inc.: Amantadine HCl Capsules Recalled for Failed Dissolution Specifications

Agency Publication Date: April 17, 2018
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Summary

AVKARE Inc. has recalled 2,135 cartons of Amantadine HCl Capsules, USP, 100 mg, which is a prescription medication (generic Symmetrel) used to treat Parkinson's disease and certain viral infections. The recall was initiated because the product failed dissolution specifications, meaning the capsules may not dissolve properly in the body to release the active medicine as intended. This specific recall affects 50-count unit dose cartons (5x10) from lot 16719 with an expiration date of 07/2018.

Risk

If the medication does not dissolve correctly, the patient may receive an inconsistent dose or an insufficient amount of the drug, which can lead to a loss of symptom control or reduced effectiveness of the treatment. No specific injuries or adverse events have been reported in the recall data.

What You Should Do

  1. Check your medication packaging for Amantadine HCl Capsules, USP, 100 mg (NDC 50268-069-15) and look for lot number 16719 with an expiration date of 07/2018.
  2. If you have the affected medication, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription.
  3. Return any unused portions of the recalled medication to your pharmacy for a refund and further instructions on safe disposal.
  4. Contact AVKARE Inc. for more information regarding this recall at their Pulaski, Tennessee facility.
  5. For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unit Dose
Model:
NDC 50268-069-15
Recall #: D-0633-2018
Lot Numbers:
16719 (Exp. 07/2018)
Date Ranges: Exp. 07/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79680
Status: Resolved
Manufacturer: AVKARE Inc.
Sold By: pharmacies
Manufactured In: United States
Units Affected: 2135 cartons
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.