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

Lot, batch or date codesLot: 25102464B, Expiry: 26NOV2025; 25102370A, Expiry: 20OCT2025; 25102369A, Expiry: 19OCT2025.

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.

Nationwide

Questions about this recall

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 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.

Other products in this recall event

2 other products · FDA event 97779

This product is part of a recall event; the main page for the event is Ketamine Hydrochloride, 50mg/ (10mg/mL), Injection recalled.

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025	CLASS III	Ketamine Hydrochloride, 50mg/ (10mg/mL), Injection recalled	Staq Pharma	Other	Nationwide
22 Oct 2025	CLASS III	Hydromorphone HCL PF, 10mg/ (0.2mg/mL) in Nacl recalled by STAQ Pharma	Staq Pharma	Other	Nationwide

More recalls from Staq Pharma

All 6

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Drug	CLASS III	Hydromorphone HCL PF, 10mg/ (0.2mg/mL) in Nacl recalled by STAQ Pharma	Staq Pharma	Other	Nationwide
22 Oct 2025Drug	CLASS III	Ketamine Hydrochloride, 50mg/ (10mg/mL), Injection recalled	Staq Pharma	Other	Nationwide
13 Dec 2023Drug	CLASS II	ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg recalled	Staq Pharma	Packaging Defects	Nationwide
23 Feb 2022Drug	CLASS I	Morphine Sulfate PF 25 mg/ (1 mg/mL) in NaCl in Single Dose Syringe recalled	Staq Pharma	Labeling Errors	CO, OH, TX
23 Feb 2022Drug	CLASS I	HYDROmorphone HCl PF 10 mg/ (0.2mg/mL) in NaCl recalled by STAQ Pharma	Staq Pharma	Labeling Errors	CO, OH, TX

Other Fentanyl Pf recalls

All 9

Reported	Class	Recall	Company	Reason	Where
2 Apr 2025Drug	CLASS II	fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma	QuVa Pharma	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma	QuVa Pharma	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	fentaNYL Citrate PF 200 mcg recalled by QuVa Pharma	QuVa Pharma	Sterility	Nationwide
7 Feb 2024Drug	CLASS I	FentaNYL citrate PF, 2500 mcg per 0.9% Sodium Chloride recalled	Denver Solutions	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS I	FentaNYL citrate PF, 1000 mcg per 0.9% Sodium Chloride recalled	Denver Solutions	Potency & Assay	Nationwide