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Stop using now Drug recall · FDA · Published September 9, 2021

Jacobus Ruzurgi 10mg Tablets Recall: Microbial Contamination Risk

Jacobus Pharmaceutical recalls Ruzurgi 10mg tablets due to microbial contamination. Products may contain excessive aerobic bacteria, yeast, or mold. Stop using affected lots immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0008-2022DrugJacobus Pharmaceutical ›
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Contact the company

Recalling firmJacobus Pharmaceutical Company Inc.Industrial Research Laboratory Building, 31 Schalks Crossing Rd · Plainsboro, NJ 08536
✎ GovInfoNow plain-language explainer

Jacobus Pharmaceutical is recalling Ruzurgi (amifampridine) 10mg tablets because they were contaminated with harmful bacteria, yeast, and mold. This poses a risk of infection or illness if taken. Affected products must be stopped and discarded. Read more at govinfonow.com/recall/35860-jacobus-ruzurgi-10mg-tablets-recall-microbial-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35860-jacobus-ruzurgi-10mg-tablets-recall-microbial-contamination-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0008-2022

Cite this page

“Jacobus Ruzurgi 10mg Tablets Recall: Microbial Contamination Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35860-jacobus-ruzurgi-10mg-tablets-recall-microbial-contamination-risk. Based on FDA recall #D-0008-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0008-2022%22&limit=1).

The FDA announced on Sept. 9, 2021, that Jacobus Pharmaceutical Company Inc. voluntarily recalled Ruzurgi (amifampridine) Tablets 10 mg due to microbial contamination risks. The Class I recall affects 2,324 bottles distributed in the USA and Canada.

How to tell if you have it

  • Brand: Jacobus Pharmaceutical
  • Product: Ruzurgi (amifampridine) Tablets 10 mg
  • Packaging: 100-count bottles
  • NDC: 49938-110-01
  • Lot codes: 18038, 18039 (Exp 03/2023); 18079 (Exp 05/2023)
  • Quantity: 2,324 bottles

The hazard

The FDA stated that the firm's testing found lots exceeded specifications for aerobic bacteria, yeast, and mold counts. This microbial contamination of non-sterile products poses a health risk to consumers.

Context

GovInfoNow records show other recent recalls include Fresenius Kabi Famotidine Injection (2025-11-06) and JB Chemicals Cetirizine Tablets (2026-06-24). Alembic also recalled Fesoterodine Tablets on 2025-12-16 due to impurity risks.

How to tell if you have this one

Check for Ruzurgi 10mg tablets in 100-count bottles, Rx only, manufactured by Jacobus Pharmaceutical. Look for lot numbers 18038, 18039 (expiring 03/2023) or 18079 (expiring 05/2023).

  • Brand
    Jacobus Pharmaceutical
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    Discard all affected Ruzurgi tablets as they may cause infection or illness.

How this recall unfolded

Recall timeline

FDA terminated this recall 5 months after the firm started it.

1. Firm started the recall: Sep 9, 202112. Published in FDA’s Enforcement Report: Oct 6, 202123. FDA classified it Class I: Oct 8, 202134. FDA terminated the recall: Feb 18, 2022420212022
  1. Firm started the recall
  2. Published in FDA’s Enforcement Report
  3. FDA classified it Class I
  4. 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-0008-2022 (September 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0008-2022 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.
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