HIGHFDA DRUG

STAQ Pharma FentaNYL Citrate PF IV Injection Recall 2025 Over Labeling Errors

STAQ Pharma recalled FentaNYL Citrate PF IV injection nationwide after labeling left incorrect or missing lot and expiration dates. Healthcare providers must stop using the product immediately. STAQ Pharma will provide recall instructions by letter.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
October 9, 2025
Status
ACTIVE
Severity
7/10

Quick Facts at a Glance

Recall Date
October 9, 2025
Hazard Level
HIGH
Brand
STAQ Pharma
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
STAQ Pharma
Product type
Intravenous injection solution
Model numbers
Lot: 25102464B, 25102370A, 25102369A
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    October 9, 2025

  2. Reported by FDA DRUG

    October 22, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Labeling: Incorrect or Missing Lot and/or Exp Date

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact STAQ Pharma, Inc. or your healthcare provider for guidance. Notification method: Letter

About This Product

FentaNYL Citrate PF is an injectable fentanyl product used for analgesia in clinical settings. It is supplied in 50 mL syringes for IV administration.

Why This Is Dangerous

Labeling errors can cause administration of the wrong lot or an expired product, potentially compromising safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals and clinics must verify lot numbers and expiration dates to avoid dosing errors and ensure proper traceability.

Practical Guidance

How to identify if yours is affected

  1. Check the packaging for NDC 73177-0102-05.
  2. Check Lot: 25102464B, 25102370A, 25102369A.
  3. Verify expiration date on the package.

Where to find product info

Recall notice on FDA enforcement page and manufacturer communications.

What timeline to expect

Recall letters will provide replacement or refund instructions; timeline not specified.

If the manufacturer is unresponsive

  • Document attempts to contact the manufacturer.
  • File a complaint with the FDA if needed.

How to prevent similar issues

  • Verify labeling for all drug orders before administration.
  • Keep shelves organized to avoid using misdated lots.
  • Use standard hospital recall procedures for drug validation.

Documentation advice

Keep recall letter, photos of the packaging, lot numbers, and NDC; record communications with the manufacturer.

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Product Details

Product: FentaNYL Citrate PF IV injection, 500mcg/50mL (10mcg/mL) in NaCl, 50 mL syringe. Brand: STAQ Pharma. NDC: 73177-0102-05. Lot numbers: 25102369A, 25102370A, 25102464B. Sold nationwide in the U.S.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Recall date 2025-10-09; status ACTIVE
  • Hazard level HIGH

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot: 25102464B
25102370A
25102369A
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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