CLASS II ONGOING Drug recall · Reported 5 Apr 2023 · FDA Enforcement Report
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg recalled
Apollo Care is recalling Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 0.9% Sodium, distributed in Missouri. The recall was initiated on 8 Feb 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0487-2023
- FDA event ID
- 91674
- Recalling firm
- Apollo Care, Columbia, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Feb 2023
- FDA classified
- 24 Mar 2023
- Reported
- 5 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 8 Feb 2023 | Recall initiated by company | |
| 24 Mar 2023 | Classified by FDA | +44 days |
| 5 Apr 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
Where it was distributed
MO
Questions about this recall
Why was it recalled?
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Which lots are affected?
Lot #: AC-016581
Where was it sold?
MO
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Apollo Care
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Semaglutide 5mg (1mg/mL), Glycine 25 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 4.5mg (0.9 mg/mL) Sterile Multi-Dose Vial recalled | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 9mg (4.5 mg/mL) Sterile Multi-Dose Vial recalled | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 10mg (5mg/mL), Glycine 10 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |
| Drug | CLASS II | Semaglutide 20mg (5mg/mL), Glycine 20 mg recalled by Apollo Care | Apollo Care | Particulate Matter | Nationwide |