Lymol Medical Recalls Sclerosol Intrapleural Aerosol Due to Leakage
Lymol Medical recalls Sclerosol Intrapleural Aerosol (sterile talc powder) due to a defective stem valve causing propellant leakage and inadequate drug delivery.
Use caution until it’s fixed
Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.
Contact the company
What happened, in plain English
Lymol Medical is recalling Sclerosol Intrapleural Aerosol, a sterile talc powder used for intrapleural administration. The recall affects 25,007 canisters distributed nationwide because the device's stem valve may be defective. This defect can cause the propellant to leak, resulting in no drug or an inadequate amount of drug being delivered to the patient. Read more at govinfonow.com/recall/42856-lymol-medical-recalls-sclerosol-intrapleural-aerosol-due-to-leakage.
Source Summary by GovInfoNow · govinfonow.com/recall/42856-lymol-medical-recalls-sclerosol-intrapleural-aerosol-due-to-leakage · Updated October 9, 2026 · FDA enforcement record: FDA #D-0858-2016
Cite this page
“Lymol Medical Recalls Sclerosol Intrapleural Aerosol Due to Leakage.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42856-lymol-medical-recalls-sclerosol-intrapleural-aerosol-due-to-leakage. Based on FDA recall #D-0858-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0858-2016%22&limit=1).
Why it’s dangerous
The defective stem valve in the spray canister allows the propellant to leak out. As a result, the device may deliver no drug or an inadequate amount of the drug when administered, potentially compromising the intended medical treatment.
Who’s affected
Patients who have been prescribed Sclerosol Intrapleural Aerosol for intrapleural administration are affected. The specific risk applies to those using canisters from Lot #4L034 with an expiration date of May 2017.
How to tell if you have this one
Check if you have Sclerosol Intrapleural Aerosol (sterile talc powder), 4 g Canister, Rx Only. Look for NDC 63256-100-30 and Lot #4L034 with an expiration date of MAY 2017. The product was distributed by Bryan Corporation in Woburn, MA.
- Brand
Lymol Medical- Category
Drug
What to do — step by step
Check your medication details
Verify if your canister matches NDC 63256-100-30 and Lot #4L034 with an expiration of MAY 2017.
Contact your healthcare provider
Consult your doctor or pharmacist regarding the defective delivery system and appropriate next steps for your treatment.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.9 years 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.
Questions people ask
What is the NDC number for the recalled item?
The National Drug Code (NDC) is 63256-100-30.
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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-0858-2016 (April 28, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0858-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.