Stop using nowDrug recall · FDA · Published February 8, 2023
Apollo Care Fentanyl/Ropivacaine Epidural Solution Recall: Sterility Risk
Apollo Care recalls specific epidural solution due to suspected microbial growth in packaging. Affected units have NDC 71170-950-25 and lot AC-016581. Stop using immediately to avoid infection risks.
“Apollo Care Fentanyl/Ropivacaine Epidural Solution Recall: Sterility Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33898-apollo-care-fentanyl-ropivacaine-epidural-solution-recall-sterility-risk. Based on FDA recall #D-0487-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0487-2023%22&limit=1).
The FDA announced on Feb. 8, 2023, that Apollo Care voluntarily recalled Fentanyl and Ropivacaine epidural bags due to suspected microbial growth on external packaging. The agency issued recall number D-0487-2023 for the Class II violation.
How to tell if you have it
Brand: Apollo Care
Product: Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only
NDC: 71170-950-25
Lot #: AC-016581
Quantity: 215 bags
Distribution: MO
The hazard
The recall addresses a lack of assurance of sterility, specifically suspected microbial growth present on the external label packaging. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Apollo Care has 3 other recalls on record since 2018-02-15. Other recent recalls of similar products include EPINEPHR Sterility Risk in 1 mg/10mL Injection Recall (2026-04-01), Huons Co. Bupivacaine Ampules Recall: Lack of Sterility Assurance (2026-04-02), and K.C. Pharmaceuticals Ultra Lubricating Eye Drops Recall: Lack of Sterility Risk (2026-03-03).
How to tell if you have this one
Check for the NDC number 71170-950-25 and lot number AC-016581 on the packaging. This product was sold through specific medical channels in Columbia, Missouri.
Brand
Apollo Care
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
Discard the product if you have the recalled batch with NDC 71170-950-25 and lot AC-016581.
Where it went and when
Where it was distributed
Distributed in Missouri.
Listed by the agency
Not listed
FDA distribution: “MO” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Missouri.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0487-2023 (February 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0487-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.