CLASS III ONGOING Drug recall · Reported 22 Oct 2025 · FDA Enforcement Report
FentaNYL Citrate PF, 500mcg/ (10mcg/mL) in Nacl recalled by STAQ Pharma
STAQ Pharma is recalling FentaNYL Citrate PF, 500mcg/ (10mcg/mL) in Nacl, Injection for IV use syringe, Staq, distributed nationwide in the US. The recall was initiated on 9 Oct 2025 and the FDA has classified it as Class III.
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-0025-2026
- FDA event ID
- 97779
- Recalling firm
- STAQ Pharma, Denver, CO
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 9 Oct 2025
- FDA classified
- 15 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 9 Oct 2025 | Recall initiated by company | |
| 15 Oct 2025 | Classified by FDA | +6 days |
| 22 Oct 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Is FentaNYL Citrate PF, 500mcg/ (10mcg/mL) in Nacl, Injection for IV use syringe, Staq recalled?
Yes. STAQ Pharma recalled FentaNYL Citrate PF, 500mcg/ (10mcg/mL) in Nacl, Injection for IV use syringe, Staq on 9 Oct 2025. The recall is Class III and its status is Ongoing. Recall number D-0025-2026.
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date
Which lots are affected?
Lot: 25102464B, Expiry: 26NOV2025; 25102370A, Expiry: 20OCT2025; 25102369A, Expiry: 19OCT2025.
Where was it sold?
Nationwide in the U.S.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 STAQ Pharma
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydromorphone HCL PF, 10mg/ 2mg/mL) in Nacl, Injection recalled | STAQ Pharma | Other | Nationwide |
| Drug | CLASS III | Ketamine Hydrochloride, 50mg/ (10mg/mL), Injection recalled | STAQ Pharma | Other | Nationwide |
| Drug | CLASS II | ROPivacaine HCl 2% PF in Sodium Chloride 1,000 mg recalled | STAQ Pharma | Packaging Defects | Nationwide |
| Drug | CLASS I | Morphine Sulfate PF 25 mg/ (1 mg/mL) in NaCl in Single Dose Syringe recalled | STAQ Pharma | Labeling Errors | CO, OH, TX |
| Drug | CLASS I | HYDROmorphone HCl PF 10 mg/ 2mg/mL) in NaCl in Single Dose Syringe recalled | STAQ Pharma | Labeling Errors | CO, OH, TX |