American Health Packaging Nitrofurantoin Capsules Recall: Dissolution Failure Risk
American Health Packaging recalls Nitrofurantoin Capsules due to dissolution failure at 0-time. This may affect drug effectiveness. Check product details to see if you have the recalled batch.
Lower-risk recall
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
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What happened, in plain English
American Health Packaging is recalling Nitrofurantoin Capsules because they failed to dissolve properly at the time of repackaging. This could mean the medication doesn't work as intended when taken. Read more at govinfonow.com/recall/34796-american-health-packaging-nitrofurantoin-capsules-recall-dissolution-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/34796-american-health-packaging-nitrofurantoin-capsules-recall-dissolution-failure-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0880-2022
Cite this page
“American Health Packaging Nitrofurantoin Capsules Recall: Dissolution Failure Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34796-american-health-packaging-nitrofurantoin-capsules-recall-dissolution-failure-risk. Based on FDA recall #D-0880-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0880-2022%22&limit=1).
Why it’s dangerous
The capsules failed to dissolve properly at the time of repackaging, which means the medication might not release correctly in the body. This could lead to reduced effectiveness of the drug for treating urinary tract infections.
Who’s affected
People who have the specific Nitrofurantoin Capsules with NDC 68084-446-11 and Lot # 1003829 are affected. Those taking the medication for urinary tract infections may be at risk if the capsules don't dissolve correctly.
How to tell if you have this one
Check for Nitrofurantoin Capsules with NDC 68084-446-11 and Lot # 1003829. The product comes in 10-count blisters per card, 10 cards per carton, and is only available by prescription.
- Brand
American Health Packaging- Category
Drug
What to do — step by step
Check Product Details
Identify if your Nitrofurantoin Capsules have NDC 68084-446-11 and Lot # 1003829.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0880-2022 (May 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0880-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.