Sun Pharmaceutical Nitrofurantoin Capsules Recall: Failed Dissolution Specifications
Sun Pharmaceutical recalls Nitrofurantoin Capsules (100mg) due to failed dissolution specifications. This may affect medication effectiveness. Check NDC 57664-233-88 and lot numbers 231067, 231069.
Lower-risk recall
Failed Dissolution Specifications
Contact the company
What happened, in plain English
Sun Pharmaceutical is recalling Nitrofurantoin Capsules (100mg) because they failed dissolution specifications. This could mean the medication doesn't work as intended, so users should check if they have the recalled batch. Read more at govinfonow.com/recall/32591-sun-pharmaceutical-nitrofurantoin-capsules-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/32591-sun-pharmaceutical-nitrofurantoin-capsules-recall-failed-dissolution-specifications · Updated August 17, 2026 · FDA enforcement record: FDA #D-0597-2024
Cite this page
“Sun Pharmaceutical Nitrofurantoin Capsules Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32591-sun-pharmaceutical-nitrofurantoin-capsules-recall-failed-dissolution-specifications. Based on FDA recall #D-0597-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0597-2024%22&limit=1).
Why it’s dangerous
The capsules failed to dissolve properly as required by the manufacturer. This could lead to the medication not working effectively when taken, potentially causing treatment failure for urinary tract infections.
Who’s affected
People who have the recalled Nitrofurantoin Capsules (100mg) from Sun Pharmaceutical, specifically those with NDC 57664-233-88 and lot numbers 231067 or 231069. Patients on prescription for urinary tract infections are most at risk.
How to tell if you have this one
Check the product label for NDC 57664-233-88 and lot numbers 231067 or 231069. The capsules are sold by Sun Pharmaceutical and distributed in the US under prescription.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 57664-233-88 and lot numbers 231067 or 231069 on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto rico” 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 II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Sun Pharmaceutical recalls
Keep exploring
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-0597-2024 (July 9, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0597-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.