Hydromorphone syringes recalled over incorrect or missing lot and expiry
STAQ Pharma is recalling one lot of Hydromorphone HCL PF 10mg/50 mL injection syringes because of incorrect or missing lot and expiration date information on the label.
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: 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
Hydromorphone HCL PF, 10mg/50 mL (0.2mg/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 lot 25104595A, expiring 27 December 2025, carrying NDC 73177-0104-05. 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 lot should follow the firm's instructions.
The recalled product
- Product
- Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.
- 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 (2)
- Lot #: 25104595A
- Expiry: 27DEC2025.
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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