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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

Alvogen, Inc: Nitrofurantoin and Macrobid Capsules Recalled for Failed Dissolution

Agency Publication Date: August 12, 2019
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Summary

Alvogen, Inc. is recalling approximately 7,056 bottles of Nitrofurantoin Monohydrate/Macrocrystals and Macrobid (nitrofurantoin monohydrate/macrocrystals) capsules, which are used to treat urinary tract infections. These medications were found to fail dissolution specifications, meaning the drug may not dissolve properly in the body. If the medication does not dissolve as intended, it may not be absorbed correctly, potentially reducing the effectiveness of the antibiotic treatment. Consumers who have these medications should contact their healthcare provider or pharmacist for guidance and to obtain a replacement prescription.

Risk

The drug failed to meet dissolution standards, which can lead to lower-than-intended levels of the medication in the bloodstream, potentially resulting in treatment failure for urinary tract infections.

What You Should Do

  1. Check your medication bottle for Nitrofurantoin Monohydrate/Macrocrystals Capsules (100 mg, 100-count) with NDC 47781-303-01 and Lot 471976 (Exp 03/2020).
  2. Check your medication bottle for Macrobid Urinary Tract Antibacterial (100 mg, 100-count) with NDC 52427-285-01 and Lot 472990 (Exp 03/2020).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you need a replacement prescription.
  4. Return any unused portion of the affected medication to the pharmacy where it was purchased for a refund.
  5. Contact Alvogen, Inc. at their Pine Brook, New Jersey office for further instructions regarding this recall.
  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
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Nitrofurantoin Monohydrate/Macrycrystals Capsules (100-count bottle)
Model:
NDC 47781-303-01
Recall #: D-1722-2019
Lot Numbers:
471976 (Exp 03/2020)
Date Ranges: Expiration 03/2020
Product: Macrobid Urinary Tract Antibacterial (100-count bottle)
Model:
NDC 52427-285-01
Recall #: D-1723-2019
Lot Numbers:
472990 (Exp 03/2020)
Date Ranges: Expiration 03/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83434
Status: Resolved
Manufacturer: Alvogen, Inc
Sold By: Retail Pharmacies
Manufactured In: United States
Units Affected: 2 products (2784 bottles; 4272 bottles)
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.