FDAClass IIMay 14, 2025

FentaNYL 500mcg recall: Sterility Concern

FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile…

Why was FentaNYL 500mcg recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot AC-016878, exp date 6/16/2025

Product
FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile…
Recalling firm
Apollo Care, LLC
Quantity
440 bags
Distribution
MO
Recall date
May 14, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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