Fentanyl citrate syringes recalled over incorrect or missing lot and expiry
STAQ Pharma is recalling three lots of FentaNYL Citrate PF 500mcg/50 mL injection syringes because of incorrect or missing lot and expiration date information on the label.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as an FDA Class III labelling error, which the rubric places at 1 or 2; the missing lot and expiry data affects traceability rather than the product itself.
Plain-English summary
FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in sodium chloride, for intravenous use in a 50 mL syringe, from STAQ Pharma of Denver, Colorado, is being recalled for a labeling problem: incorrect or missing lot and/or expiration date.
The recall covers lots 25102464B (expiring 26 November 2025), 25102370A (expiring 20 October 2025) and 25102369A (expiring 19 October 2025), carrying NDC 73177-0102-05. The product was distributed nationwide in the United States. The FDA has classified the recall as Class III.
The enforcement record describes the label information rather than any defect in the drug itself, and reports no injuries. Missing lot or expiry data does, however, remove the information a clinician would use to check whether a syringe is still in date.
Facilities holding the affected lots should follow the firm's instructions.
The recalled product
- 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.
- Manufacturer
- STAQ Pharma, Inc.
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot: 25102464B
- Expiry: 26NOV2025
- 25102370A
- Expiry: 20OCT2025
- 25102369A
- Expiry: 19OCT2025.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by STAQ Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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