Nostrum Labs Nitrofurantoin Recall: Failed Dissolution Specs
Nostrum Laboratories recalls Nitrofurantoin Oral Suspension due to failed dissolution specifications. Check lot numbers BZP0093A-BZP0097A and expiration date 02/2017.
Use caution until it’s fixed
Failed Dissolution Specifications
Contact the company
What happened, in plain English
Nostrum Laboratories, Inc. is recalling Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL because the product failed dissolution specifications. This means the medication may not release or absorb properly in the body, potentially reducing its effectiveness as a urinary tract antibacterial. The recall affects 2,839 bottles distributed nationwide. Read more at govinfonow.com/recall/42604-nostrum-labs-nitrofurantoin-recall-failed-dissolution-specs.
Source Summary by GovInfoNow · govinfonow.com/recall/42604-nostrum-labs-nitrofurantoin-recall-failed-dissolution-specs · Updated October 9, 2026 · FDA enforcement record: FDA #D-1030-2016
Cite this page
“Nostrum Labs Nitrofurantoin Recall: Failed Dissolution Specs.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42604-nostrum-labs-nitrofurantoin-recall-failed-dissolution-specs. Based on FDA recall #D-1030-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1030-2016%22&limit=1).
Why it’s dangerous
The hazard is that the drug failed dissolution specifications, which can prevent the active ingredient from being released correctly. This failure may result in the medication not treating the infection effectively, leading to continued illness or complications.
Who’s affected
Patients prescribed Nitrofurantoin Oral Suspension by Nostrum Laboratories who purchased the recalled lots between distribution and the recall date are affected. Individuals relying on this specific medication for urinary tract infections may receive a product that does not work as intended.
How to tell if you have this one
Check your bottle for the label 'Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL' distributed by Sun Pharmaceutical Industries, Inc. Look for NDC 57664-239-32 and any of the following lot numbers: BZP0093A, BZP0094A, BZP0095A, BZP0096A, or BZP0097A. The expiration date on these bottles is 02/2017.
- Brand
Nostrum Laboratories- Category
Drug
What to do — step by step
Check your medication
Verify if your Nitrofurantoin Oral Suspension bottle matches the recalled NDC, lot numbers (BZP0093A-BZP0097A), and expiration date of 02/2017.
Contact your pharmacist
If you have the recalled product, contact your pharmacy or healthcare provider to discuss obtaining a replacement or alternative treatment.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 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.
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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-1030-2016 (May 23, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1030-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.