HIGHFDA DRUG

STAQ Pharma Hydromorphone HCl PF 10mg/50mL IV Injection Recall for Labeling Errors (2025)

STAQ Pharma’s Hydromorphone HCl PF 10mg/50mL IV injection recall affects nationwide distribution in the United States. The recall cites labeling errors involving incorrect or missing lot and expiration dates. Healthcare providers and patients must stop using the product and follow guidance from STAQ Pharma or their clinician.

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
Multiple Retailers
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 Hydromorphone Injection
Model numbers
25104595A, Expiry 27DEC2025
Sold at
Multiple Retailers
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

Hydromorphone HCl PF is a prescription opioid analgesic prepared for intravenous use in medical settings. Correct lot and expiry labeling is essential for patient safety.

Why This Is Dangerous

Incorrect or missing lot and expiry data can lead to incorrect identification or administration of expired product, posing patient safety risks.

Industry Context

This recall is not presented as part of a broader industry pattern.

Real-World Impact

Hospitals and clinics must verify labeling before use; patients could experience treatment delays or dosing errors during recall replacements.

Practical Guidance

How to identify if yours is affected

  1. Locate the product label for Lot 25104595A and Expiry 27DEC2025
  2. Cross-check NDC 73177-0104-05 on the packaging
  3. Review inventory logs for recent distributions of this lot

Where to find product info

Label on syringe packaging and accompanying documentation; NDC on the label

What timeline to expect

Not specified; follow STAQ Pharma recall communications for remediation timelines

If the manufacturer is unresponsive

  • Document all attempts to contact STAQ Pharma
  • Coordinate with hospital recalls office or pharmacists
  • File a recall complaint with FDA if necessary

How to prevent similar issues

  • Implement double-checks for lot/expiry during receiving and administration
  • Use electronic inventory controls with expiry warnings
  • Regularly review FDA recall notices for drug labeling issues

Documentation advice

Keep copy of recall notice, lot and expiry records, and all correspondence with STAQ Pharma

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Product Details

Model numbers/identifiers: Lot 25104595A; Expiry 27DEC2025. Sold nationwide through medical facilities and distributors. NDC 73177-0104-05. Manufacturer: STAQ Pharma, Inc., 14135 E 42nd Ave, Denver, CO.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Hydromorphone HCl PF, 10mg/50mL in saline for IV use
  • Nationwide U.S. distribution
  • Active recall as of 2025-10-22

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 Details

Model Numbers
25104595A
Expiry 27DEC2025
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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