Ruzurgi — Class I drug recall D-0008-2022
Terminated recall by Jacobus Pharmaceutical Company Inc., reported 2021-10-06. Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic
| Recall number | D-0008-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jacobus Pharmaceutical Company Inc., Plainsboro, NJ, United States |
| Recall initiated | 2021-09-09 |
| Classified | 2021-10-08 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2022-02-18 |
| Countries outside the US | CA |
| Quantity | 2,324 bottles |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold, yeast |
| NDC | 49938-0110-01 |
| Lot numbers | 18038, 18039, 18079 |
| Expiration dates | 2023-03, 2023-05 |
Product
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.
Reason for recall
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0008-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.