Skip to content
Drug recall · FDA · Published December 4, 2024

AvKARE recalls Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE,

AvKARE recalls 100 mg Nitrofurantoin Capsules due to failed dissolution specifications. This may affect medication effectiveness. Check NDC# 50268-625-15 and lot # 47101 for affected units.

🇺🇸 FDA recall #D-0168-2025DrugAvKARE ›
Take action

Contact the company & request your remedy

Recalling firmAvKARE615 N 1st St · Pulaski, TN 38478-2403
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

AvKARE is recalling 100 mg Nitrofurantoin Capsules that failed dissolution specifications. This could mean the medication doesn't work properly when taken as intended. Read more at govinfonow.com/recall/32388-avkare-nitrofurantoin-capsules-recall-failed-dissolution-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/32388-avkare-nitrofurantoin-capsules-recall-failed-dissolution-specifications · Updated September 23, 2026 · FDA enforcement record: FDA #D-0168-2025

Cite this page

“AvKARE Nitrofurantoin Capsules Recall: Failed Dissolution Specifications.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32388-avkare-nitrofurantoin-capsules-recall-failed-dissolution-specifications. Based on FDA recall #D-0168-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0168-2025%22&limit=1).

Why it’s dangerous

The capsules failed to dissolve properly as required by the drug's specifications. This could lead to the medication not working effectively when taken.

Who’s affected

People who have prescription Nitrofurantoin Capsules with NDC# 50268-625-15 and lot # 47101 are affected. Those with the medication for urinary tract infections are most at risk.

How to tell if you have this one

Check for NDC# 50268-625-15 and lot # 47101 on the packaging. The product is a prescription-only medication for urinary tract infections.

  • Brand
    AvKARE
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for NDC# 50268-625-15 and lot # 47101 on the packaging.

✎ 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 can I check if I have the recalled product?

Check for NDC# 50268-625-15 and lot # 47101 on the packaging. This product is prescription-only for urinary tract infections.

What should I do if I have the recalled product?

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

Take action

Contact AvKARE

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

Subject: Recall D-0168-2025 — AvKARE AvKARE

Hello,

I own a AvKARE that is covered by recall D-0168-2025 from AvKARE.

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.

Similar recalls

Keep exploring

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

Comments are reviewed before they appear. No links, ads, or personal attacks — those get removed.

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-0168-2025 (December 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0168-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 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