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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: Nitrofurantoin Capsules Recalled for Potential Cross-Contamination

Agency Publication Date: November 20, 2018
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Summary

American Health Packaging is recalling 4,508 blister packs of Nitrofurantoin Capsules USP (100 mg), a prescription antibiotic used to treat urinary tract infections. This recall was initiated because the medication may contain trace amounts of unrelated active ingredients, specifically Benazepril, Haloperidol, and Perphenazine, due to a manufacturing issue at the original production facility. These affected 100-count unit dose blisters were distributed nationwide across the United States.

Risk

The presence of unintended active pharmaceutical ingredients like Haloperidol (an antipsychotic) or Benazepril (a blood pressure medication) poses a risk of adverse drug reactions or unintended side effects if consumed. No specific injuries or incidents were reported in this data, but the contamination was identified during a manufacturing investigation.

What You Should Do

  1. Check your medication packaging for Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, in 100-count Unit Dose Blisters.
  2. Identify if your product is affected by looking for Lot numbers 180310 or 180612 with an expiration date of 03/31/20.
  3. Verify the NDC numbers on the packaging: the 100-count pack NDC is 68084-446-01 and the individual dose NDC is 68064-446-11.
  4. If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance on your treatment and to obtain a safe replacement.
  5. Return any unused portions of the recalled medication to your pharmacy for a refund and contact American Health Packaging for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and pharmacy return

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

Affected Products

Product: Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg (100-count Unit Dose Blisters)
Model:
NDC 68084-446-01
Individual Dose NDC 68064-446-11
Recall #: D-0273-2019
Lot Numbers:
180310 (Exp 03/31/20)
180612 (Exp 03/31/20)
Date Ranges: Expiration 03/31/20

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81553
Status: Resolved
Manufacturer: AMERICAN HEALTH PACKAGING
Sold By: Amerisource Health Services; American Health Packaging
Manufactured In: United States
Units Affected: 4508 blister packs
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.