Johnson Matthey Inc. recalls Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass
Johnson Matthey recalls Remifentanil HCl active pharmaceutical ingredient due to unknown impurities exceeding safety limits. This API is used in manufacturing and repackaging. No remedy specified in official notice.
Recall notice
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Contact the company & request your remedy
What happened, in plain English
Johnson Mat: Remifentanil HCl active pharmaceutical ingredient (API) is being recalled because it contains unknown impurities above safety limits. This API is used in manufacturing and repackaging processes. The recall affects specific lots produced in 2003. Read more at govinfonow.com/recall/38973-johnson-matthey-remifentanil-api-recall-unknown-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38973-johnson-matthey-remifentanil-api-recall-unknown-impurities-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1252-2019
Cite this page
“Johnson Matthey Remifentanil API Recall: Unknown Impurities Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38973-johnson-matthey-remifentanil-api-recall-unknown-impurities-risk. Based on FDA recall #D-1252-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1252-2019%22&limit=1).
Why it’s dangerous
The API contains unknown impurities that exceed safety limits. This could potentially cause harm during manufacturing or repackaging processes. The exact risk level is not clearly described in the recall notice.
Who’s affected
Manufacturers and repackagers who use this Remifentanil HCl API in their processes are affected. Those handling the specific lot B1319-170101 are at risk.
How to tell if you have this one
Check for the Remifentanil HCl API with lot number B1319-170101. This product is a 416.95 g glass container used for manufacturing and repackaging only.
- Brand
Johnson Matthey- Category
Drug
What to do — step by step
Check Product Details
Identify the lot number on the glass container to determine if it matches B1319-170101.
Questions people ask
Is this product safe to use?
The recall notice states the API contains unknown impurities above safety limits, but does not specify if it is safe to use.
What should I do if I have this product?
The official recall notice does not provide a remedy for this product.
How can I confirm if I have the recalled product?
Look for the Remifentanil HCl API with lot number B1319-170101 in a 416.95 g glass container.
Contact Johnson Matthey
We’ve drafted a message you can send Johnson Matthey to request your refund or repair — edit it as you like.
Subject: Recall D-1252-2019 — Johnson Matthey Johnson Matthey Hello, I own a Johnson Matthey that is covered by recall D-1252-2019 from Johnson Matthey. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1252-2019 (April 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1252-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.