FDA Recall D-0025-2026
STAQ Pharma, Inc. · Denver, CO
Class III Ongoing 217 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
Product
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.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Recall record
- Recall number
D-0025-2026- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the U.S.
- Recall initiated
- 2025-10-09
- Classified by FDA Center
- 2025-10-15
- FDA published
- 2025-10-22
- Recalling firm
- STAQ Pharma, Inc.
- Firm location
- Denver, CO
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.