Medications & Supplements/Prescription Drugs

STAQ Pharma Hydromorphone, Ketamine, and Fentanyl Recalled for Labeling Errors

Agency Publication Date: October 15, 2025

Summary

STAQ Pharma, Inc. is voluntarily recalling several injectable medications, including Hydromorphone HCL, Ketamine Hydrochloride, and Fentanyl Citrate, because the labels may have incorrect or missing lot numbers and expiration dates. This nationwide recall affects specific 50 mL syringes used in clinical and hospital settings. Because these are critical medications administered by healthcare professionals, accurate labeling is essential to ensure the correct medication is used before it expires.

Risk

Incorrect or missing expiration dates and lot numbers can lead to the use of expired products or hinder the ability to identify specific batches in the event of other safety issues, which could result in ineffective treatment or patient harm.

What You Should Do

Identify if you have the affected products by checking the lot numbers and expiration dates on the syringe labels.
For Hydromorphone HCL PF (0.2mg/mL), check for lot 25104595A with expiration date 27DEC2025.
For Ketamine Hydrochloride (10mg/mL), check for lot 25156673A with expiration date 02FEB2026.
For Fentanyl Citrate PF (10mcg/mL), check for lots 25102464B (Exp 26NOV2025), 25102370A (Exp 20OCT2025), or 25102369A (Exp 19OCT2025).
Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use (50 mL Syringe)

Variants: 0.2mg/mL, 50 mL Syringe

Lot Numbers:

25104595A (Exp 27DEC2025)

NDC:

73177-0104-05

Recall #: D-0023-2026

Product: Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use (50 mL syringe)

Variants: 10mg/mL, 50 mL syringe

Lot Numbers:

25156673A (Exp 02FEB2026)

NDC:

73177-0156-02

Recall #: D-0024-2026

Product: FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use (50 mL syringe)

Variants: 10mcg/mL, 50 mL syringe

Lot Numbers:

25102464B (Exp 26NOV2025)

25102370A (Exp 20OCT2025)

25102369A (Exp 19OCT2025)

NDC:

73177-0102-05

Recall #: D-0025-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97779

Status: Active

Manufacturer: STAQ Pharma, Inc.

Sold By: Hospitals; Wholesalers; Clinical Facilities

Manufactured In: United States

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected products by checking the lot numbers and expiration dates on the syringe labels.

For Hydromorphone HCL PF (0.2mg/mL), check for lot 25104595A with expiration date 27DEC2025.

For Ketamine Hydrochloride (10mg/mL), check for lot 25156673A with expiration date 02FEB2026.

For Fentanyl Citrate PF (10mcg/mL), check for lots 25102464B (Exp 26NOV2025), 25102370A (Exp 20OCT2025), or 25102369A (Exp 19OCT2025).

Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Affected Products

Product: Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use (50 mL Syringe)

Variants: 0.2mg/mL, 50 mL Syringe

Lot Numbers:

25104595A (Exp 27DEC2025)

NDC:

73177-0104-05

Recall #: D-0023-2026

Product: Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use (50 mL syringe)

Variants: 10mg/mL, 50 mL syringe

Lot Numbers:

25156673A (Exp 02FEB2026)

NDC:

73177-0156-02

Recall #: D-0024-2026

Product: FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use (50 mL syringe)

Variants: 10mcg/mL, 50 mL syringe

Lot Numbers:

25102464B (Exp 26NOV2025)

25102370A (Exp 20OCT2025)

25102369A (Exp 19OCT2025)

NDC:

73177-0102-05

Recall #: D-0025-2026