X-Gen Neomycin Sulfate Tablets Recall: Microbiological Assay Failure
X-Gen Pharmaceuticals recalls Neomycin Sulfate 500mg tablets due to microbiological assay failure. These prescription-only tablets may have contamination risks. Check NDC 39822-0310-5 and lot number CFMBX for affected units.
Lower-risk recall
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Contact the company
What happened, in plain English
X-Gen Pharmaceuticals is recalling prescription Neomycin Sulfate 500mg tablets that failed microbiological testing. This could mean the tablets contain harmful bacteria, posing a risk to users who take them as directed. Read more at govinfonow.com/recall/36266-x-gen-neomycin-sulfate-tablets-recall-microbiological-assay-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/36266-x-gen-neomycin-sulfate-tablets-recall-microbiological-assay-failure · Updated October 4, 2026 · FDA enforcement record: FDA #D-0328-2021
Cite this page
“X-Gen Neomycin Sulfate Tablets Recall: Microbiological Assay Failure.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36266-x-gen-neomycin-sulfate-tablets-recall-microbiological-assay-failure. Based on FDA recall #D-0328-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0328-2021%22&limit=1).
Why it’s dangerous
The tablets failed microbiological testing, meaning they may contain harmful bacteria. This could cause infections or other health issues if taken as prescribed. However, the recall is for prescription-only products, so only medical professionals would use them.
Who’s affected
Prescription patients who have the specific Neomycin Sulfate tablets with NDC 39822-0310-5 and lot number CFMBX. Those with the product are most at risk if they take it without proper medical supervision.
How to tell if you have this one
Check for the NDC code 39822-0310-5 and lot number CFMBX on the product packaging. These tablets were manufactured in Big Flats, NY and expire September 2022.
- Brand
X-Gen Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 39822-0310-5 and lot number CFMBX on the packaging to confirm if the product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed Nationwide in the 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 21 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-0328-2021 (March 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0328-2021 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.