Hydromorphone HCl (STAQ Pharma) – Labeling Mixup (2022)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0104-05.
Brand
STAQ Pharma, Inc.
Lot Codes / Batch Numbers
Lot Number: 21104221A, Expiration date: 05-22-2022
Products Sold
Lot Number: 21104221A, Expiration date: 05-22-2022
STAQ Pharma, Inc. is recalling HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, ST due to Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 2. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, OH, TX
Page updated: Jan 7, 2026