Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Ruzurgi (amifampridine) Tablets 10 mg Recalled by Jacobus Pharmaceutical Company Inc. Due to Microbial contamination of non-sterile products: Firm's testing found...

Date: September 9, 2021
Company: Jacobus Pharmaceutical Company Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Jacobus Pharmaceutical Company Inc. directly.

Affected Products

Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.

Quantity: 2,324 bottles

Why Was This Recalled?

Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.

Where Was This Sold?

Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.

About Jacobus Pharmaceutical Company Inc.

Jacobus Pharmaceutical Company Inc. has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report