Fentanyl Citrate injection recalled for missing or incorrect labeling
STAQ Pharma is recalling FentaNYL Citrate PF injection because lot and/or expiration date information is missing or incorrect on the label. Three lots are affected nationwide.
What this means for you
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: FDA Class III recall with a labeling error involving missing or incorrect lot and/or expiration date information. No illnesses or injuries have been reported. Per the rubric, FDA Class III recalls are typically scored 1 or 2; the theoretical nature of the hazard and lack of reported harm place this in the moderate category.
Plain-English summary
STAQ Pharma, Inc. is recalling FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL Injection for intravenous use supplied in 50 mL syringes due to a labeling deficiency.
The recall was initiated because lot and/or expiration date information is missing or incorrect on the product label. The affected lots are: Lot 25102464B (expiration 26 November 2025), Lot 25102370A (expiration 20 October 2025), and Lot 25102369A (expiration 19 October 2025).
The affected product has been distributed nationwide in the United States. Healthcare providers and patients who have received this product should verify the lot number and expiration date information before use. Consumers should contact STAQ Pharma, Inc. or the FDA for guidance regarding the correct labeling information and any necessary follow-up actions.
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
- Hazard
- labeling-error
- missing-lot-info
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.
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