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Drug recall · FDA · Published January 7, 2021

American Health Packaging recalls Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx

American Health Packaging recalls Nitrofurantoin Capsules USP (100mg) due to failed dissolution specifications. This may affect medication effectiveness. Contact for details.

🇺🇸 FDA recall #D-0232-2021DrugAmerican Health Packaging ›
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Contact the company & request your remedy

Recalling firmAmerican Health Packaging2550 John Glenn Ave Ste A, N/A · Columbus, OH 43217-1188
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

American Health Packaging is recalling Nitrofurantoin Capsules USP (100mg) because they failed to dissolve properly. This could mean the medication doesn't work as intended, so it's important to stop using these capsules and contact the manufacturer for a replacement. Read more at govinfonow.com/recall/36555-american-health-packaging-nitrofurantoin-capsules-recall-failed-dissolution-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/36555-american-health-packaging-nitrofurantoin-capsules-recall-failed-dissolution-specifications · Updated October 4, 2026 · FDA enforcement record: FDA #D-0232-2021

Cite this page

“American Health Packaging Nitrofurantoin Capsules Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36555-american-health-packaging-nitrofurantoin-capsules-recall-failed-dissolution-specifications. Based on FDA recall #D-0232-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0232-2021%22&limit=1).

Why it’s dangerous

The capsules failed to dissolve properly, which could mean the medication isn't working effectively. This is a quality issue with the manufacturing process, not a safety hazard that causes injury.

Who’s affected

Prescription patients who received Nitrofurantoin Capsules USP (100mg) from American Health Packaging. Those with specific medical conditions requiring this medication are most at risk.

How to tell if you have this one

Check for the NDC Carton number 68084-446-01 and NDC Blister Card number 68084-446-11 on the packaging. The lot number 193757 was produced and expires January 31, 2022.

  • Brand
    American Health Packaging
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging Details

    Look for NDC Carton 68084-446-01 and NDC Blister Card 68084-446-11 on the packaging.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The capsules failed to dissolve properly, which could mean the medication isn't working as intended.

How do I know if I have the recalled product?

Check for NDC Carton 68084-446-01 and NDC Blister Card 68084-446-11 on the packaging. The lot number 193757 expires January 31, 2022.

What should I do if I have the recalled product?

The recall record does not specify a remedy, so contact American Health Packaging for further instructions.

Take action

Contact American Health Packaging

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

Subject: Recall D-0232-2021 — American Health Packaging American Health Packaging

Hello,

I own a American Health Packaging that is covered by recall D-0232-2021 from American Health Packaging.

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-0232-2021 (January 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0232-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 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