The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0409-2025·Announced 2025-05-14

FentaNYL and Ropivacaine Epidural Injection Recalled Due to Sterility Concerns

Apollo Care, LLC is recalling FentaNYL 500mcg/2mcg/mL and Ropivacaine HCl 250mg/0.1% epidural injection due to lack of assurance of sterility. The recall affects 440 bags of a single lot distributed in Missouri.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The product is a sterile injectable drug classified as FDA Class II by the agency. Lack of assurance of sterility in an epidural injectable presents a direct risk of serious infection and hospitalization, meeting the threshold for Severe severity.

Plain-English summary

Apollo Care, LLC is recalling FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) in 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only) due to lack of assurance of sterility. The recalled product is in sterile, single-use containers for prescription use only.

This recall involves Lot AC-016878 with an expiration date of 6/16/2025. A total of 440 bags were distributed in Missouri. The product is manufactured by Apollo Care, LLC, located at 3801 Mojave Ct, Ste 101, Columbia, MO 65202, with NDC number 71170-950-25.

Patients currently using this product should contact their healthcare provider or pharmacist immediately. Healthcare providers should check their inventory for the affected lot and quarantine any remaining product. Do not administer doses from affected containers.

The recalled product

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, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25
Manufacturer
Apollo Care, LLC
Category
Drug — Injectable / Epidural
Hazard
Affected units
440

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed in 1 state:

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