Fentanyl citrate recall
FDA recall D-0178-2026 · initiated Sep 23, 2025
Park Avenue Compounding recalled Fentanyl citrate in Sep 2025 — an FDA Class II recall (D-0178-2026) because CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 189 bags
Details
- Product
- 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.
- Recalling company
- Park Avenue Compounding
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed in Missouri
- Initiated
- Sep 23, 2025
- FDA report date
- Nov 26, 2025
Frequently asked
- Was Fentanyl citrate recalled?
- Park Avenue Compounding recalled Fentanyl citrate in Sep 2025 — an FDA Class II recall (D-0178-2026) because CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Fentanyl citrate recalled?
- Per the FDA enforcement record, the reason for recall D-0178-2026 was: CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
- Is a recalled Fentanyl citrate dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fentanyl citrate are affected?
- Distributed: Distributed in Missouri. The recall covers these lots — Lot # 20250507-01D93C, Exp Date: 11-04-2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0178-2026.