FentaNYL Citrate PF recall
FDA recall D-0025-2026 · initiated Oct 9, 2025
STAQ Pharma, Inc. recalled FentaNYL Citrate PF in Oct 2025 — an FDA Class III recall (D-0025-2026) because Labeling: Incorrect or Missing Lot and/or Exp Date.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
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.
Details
- Product
- FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.
- Recalling company
- STAQ Pharma, Inc.
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the U.S.
- Initiated
- Oct 9, 2025
- FDA report date
- Oct 22, 2025
Frequently asked
- Was FentaNYL Citrate PF recalled?
- STAQ Pharma, Inc. recalled FentaNYL Citrate PF in Oct 2025 — an FDA Class III recall (D-0025-2026) because Labeling: Incorrect or Missing Lot and/or Exp Date. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was FentaNYL Citrate PF recalled?
- Per the FDA enforcement record, the reason for recall D-0025-2026 was: Labeling: Incorrect or Missing Lot and/or Exp Date
- Is a recalled FentaNYL Citrate PF 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. 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 PF are affected?
- Distributed: Nationwide in the U.S.. The recall covers these lots — Lot: 25102464B, Expiry: 26NOV2025; 25102370A, Expiry: 20OCT2025; 25102369A, Expiry: 19OCT2025.. 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-0025-2026.