Hydromorphone HCl Solution (PharMEDium) – Formulation Issue (2019)
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 in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78
Brand
PharMEDium Services, LLC
Lot Codes / Batch Numbers
Lot #: 190670030D, 190670031D, 190670032D, 190670033D, Exp. 6/9/2019, 190710015D, 190710016D, 190710017D, 190710018D, 190710019D, Exp. 6/11/2019, 190730028D, 190730029D, 190730030D, Exp. 6/13/2019, 190740018D, Exp.6/16/2019, 190770028D, 190770029D, Exp. 6/17/2019, 190780027D, 190780028D, 190780029D, Exp. 6/18/2019, 190790030D, Exp. 6/19/2019, 190800012D, 190800013D, 190800014D, 190800015D, 190800016D, Exp.6/20/2019, 190810033D, 190810034D, 190810035D, 190810036D, Exp.6/23/2019, 190840002D, Exp. 6/24/2019, 190870008D, Exp. 6/27/2019, 190910015D, Exp. 7/1/2019, 190980033D, Exp. 7/8/2019, 190990017D, 190990030D, Exp. 7/9/2019, 191000035D, Exp. 7/10/2019, 191010008D, 191010009D, 191010010D, Exp. 7/11/2019, 191050002D, Exp.7/15/2019, 191120002D, Exp.7/22/2019, 191160001D, Exp. 7/28/2019, 191210020D, 191210021D, 191210022D, Exp.7/31/2019, 191220017D, Exp.8/1/2019.
Products Sold
Lot #: 190670030D,190670031D, 190670032D, 190670033D, Exp. 6/9/2019; 190710015D, 190710016D, 190710017D, 190710018D, 190710019D, Exp. 6/11/2019; 190730028D, 190730029D, 190730030D, Exp. 6/13/2019; 190740018D, Exp.6/16/2019; 190770028D, 190770029D, Exp. 6/17/2019; 190780027D, 190780028D, 190780029D, Exp. 6/18/2019; 190790030D, Exp. 6/19/2019; 190800012D, 190800013D, 190800014D, 190800015D, 190800016D, Exp.6/20/2019; 190810033D, 190810034D, 190810035D,190810036D, Exp.6/23/2019; 190840002D, Exp. 6/24/2019; 190870008D, Exp. 6/27/2019; 190910015D, Exp. 7/1/2019; 190980033D, Exp. 7/8/2019; 190990017D, 190990030D, Exp. 7/9/2019; 191000035D, Exp. 7/10/2019; 191010008D,191010009D, 191010010D, Exp. 7/11/2019; 191050002D, Exp.7/15/2019; 191120002D, Exp.7/22/2019; 191160001D, Exp. 7/28/2019; 191210020D, 191210021D, 191210022D, Exp.7/31/2019; 191220017D, Exp.8/1/2019.
PharMEDium Services, LLC is recalling Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N D due to Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is prod. 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
Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
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 noticePage updated: Jan 7, 2026