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Drug recall · FDA · Published July 24, 2019

Alvogen, Inc recalls Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc.

Alvogen recalls 100-count Macrobid urinary tract antibacterial bottles with failed dissolution specifications. This may affect medication effectiveness.

🇺🇸 FDA recall #D-1723-2019DrugAlvogen ›
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Contact the company & request your remedy

Recalling firmAlvogen, Inc10 Bloomfield Ave Bldg B Ste 2, N/A · Pine Brook, NJ 07058-9743
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Alvogen is recalling 100-count Macrobid urinary tract antibacterial bottles that failed dissolution tests. This could mean the medication doesn't work properly when taken as directed. Read more at govinfonow.com/recall/38217-alvogen-macrobid-urinary-tract-antibacterial-failed-dissolution-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/38217-alvogen-macrobid-urinary-tract-antibacterial-failed-dissolution-specifications · Updated October 5, 2026 · FDA enforcement record: FDA #D-1723-2019

Cite this page

“Alvogen Macrobid Urinary Tract Antibacterial: Failed Dissolution Specifications.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38217-alvogen-macrobid-urinary-tract-antibacterial-failed-dissolution-specifications. Based on FDA recall #D-1723-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1723-2019%22&limit=1).

Why it’s dangerous

The medication failed dissolution specifications, meaning it may not dissolve properly in the body. This could lead to reduced effectiveness of the antibiotic in treating urinary tract infections.

Who’s affected

Prescription holders of the 100-count Macrobid bottles with NDC 52427-285-01 and lot #472990. People taking this medication for urinary tract infections may be at risk if the product doesn't dissolve correctly.

How to tell if you have this one

Check for the 100-count bottle labeled 'Macrobid Urinary Tract Antibacterial, 100 mg, Rx Only' with NDC 52427-285-01 and lot number 472990. This product was manufactured by Norwich Pharmaceuticals and distributed by Almatica Pharma.

  • Brand
    Alvogen
  • Category
    Drug
FDA recall event · 2 products

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
    Natonwide, PR
Recall numberProduct, codes & lotsQuantityNDC
D-1722-2019Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01; Lot # 471976, Exp 03/20202784 bottles47781-303-01
D-1723-2019Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01; Lot # 472990, Exp 03/20204272 bottles52427-285-01
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify if your bottle has NDC 52427-285-01 and lot #472990.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall is due to failed dissolution specifications, which may affect medication effectiveness. The product is not safe to use as intended.

How do I know if I have the recalled product?

Look for the 100-count bottle with NDC 52427-285-01 and lot #472990.

What should I do if I have the recalled product?

The recall does not specify a remedy, so contact your healthcare provider for advice.

Take action

Contact Alvogen

We’ve drafted a message you can send Alvogen to request your refund or repair — edit it as you like.

Subject: Recall D-1723-2019 — Alvogen Alvogen

Hello,

I own a Alvogen that is covered by recall D-1723-2019 from Alvogen.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1723-2019 (July 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1723-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA