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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

AMERICAN HEALTH PACKAGING: Enalapril Maleate Tablets Recalled for Impurities and Degradation

Agency Publication Date: July 9, 2018
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Summary

American Health Packaging is recalling 1,285 cartons of Enalapril Maleate (5 mg), a prescription medication used to treat high blood pressure. The recall was issued because testing found levels of a chemical impurity called Enalapril DKT that exceeded approved safety specifications. These affected cartons were distributed to wholesalers between December 2016 and September 2017. If you use this medication, you should consult your doctor or pharmacist to discuss your treatment options and ensure you have a safe supply of medication.

Risk

The tablets contain a degradant that exceeds quality limits, which means the medication does not meet purity standards. While the risk is considered low, consuming a drug with higher-than-allowed levels of impurities can potentially affect the medication's effectiveness or lead to unknown health risks over time.

What You Should Do

  1. Check your medication packaging to see if you have Enalapril Maleate Tablets USP, 5 mg, in 100-count blister cards (10x10 cards per carton).
  2. Look for NDC numbers 68084-390-01 on the carton or 68084-390-11 on the individual unit doses.
  3. Verify the lot numbers and expiration dates: check for Lot 166023 (Exp. 11/30/18) or Lot 168467 (Exp. 2/28/19).
  4. Contact your healthcare provider or pharmacist immediately for guidance on whether you should continue taking the medication or if you need a replacement prescription.
  5. Return any unused tablets from the affected lots to your pharmacy for a refund and contact American Health Packaging at their Columbus, Ohio office for further instructions.
  6. For additional questions, 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

Refund and guidance for prescription medication.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards
Model:
NDC 68084-390-01 (Carton)
NDC 68084-390-11 (Unit Dose)
Recall #: D-0915-2018
Lot Numbers:
166023 (Exp. 11/30/18)
168467 (Exp. 2/28/19)
Date Ranges: 12/29/16 to 1/19/17, 4/6/17 to 9/11/17

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80389
Status: Resolved
Manufacturer: AMERICAN HEALTH PACKAGING
Sold By: wholesalers
Manufactured In: United States
Units Affected: 1285 cartons (cartons of 100 individual unit doses)
Distributed To: Nationwide

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.