CLASS II ONGOING Drug recall · Reported 26 Nov 2025 · FDA Enforcement Report
Fentanyl citrate, 2 mcg / ml / Ropivacaine, 2% in NS, CII recalled
Park Avenue Compounding is recalling Fentanyl citrate, 2 mcg / ml / Ropivacaine, 2% in NS, CII, distributed in Missouri. The recall was initiated on 23 Sep 2025 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-0178-2026
- FDA event ID
- 97938
- Recalling firm
- Park Avenue Compounding, Saint Louis, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Sep 2025
- FDA classified
- 20 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 23 Sep 2025 | Recall initiated by company | |
| 20 Nov 2025 | Classified by FDA | +58 days |
| 26 Nov 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Product as listed by the FDA
Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.
Where it was distributed
Distributed in Missouri
Questions about this recall
Is Fentanyl citrate, 2 mcg / ml / Ropivacaine, 2% in NS, CII recalled?
Yes. Park Avenue Compounding recalled Fentanyl citrate, 2 mcg / ml / Ropivacaine, 2% in NS, CII on 23 Sep 2025. The recall is Class II and its status is Ongoing. Recall number D-0178-2026.
Why was it recalled?
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Which lots are affected?
Lot # 20250507-01D93C, Exp Date: 11-04-2025
Where was it sold?
Distributed in Missouri
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 21 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 Park Avenue Compounding
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine HCI, 1000 mcg / Total Volume recalled | Park Avenue Compounding | Manufacturing (CGMP) Deviations | MO |