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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- sterility-failure
- injection-infection-risk
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:
- MO
Related recalls
Same category
- High
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-08-05
- HighMycophenolate Mofetil Injection Recalled Due to Precipitate in Vials
FDA (Drugs) · 2026-08-05
- ModerateAzelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29