HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance
HYDROmorphone HCl Injection 30 mg/30 mL from Nephron Sterile Compounding Center LLC is being recalled nationwide due to lack of assured sterility. The recall affects 18,570 syringes across three lot numbers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a high-risk injectable medication with an unconfirmed contamination hazard. However, no illnesses or hospitalizations have been reported in the source text, placing this at the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) pre-filled syringes due to lack of assurance of sterility. The recalled product is a prescription injectable medication.
The recall affects 18,570 syringes distributed nationwide in the USA. The affected lot numbers are HN2001A (expiration 7/23/2022), HN2003A (expiration 8/19/2022), and HN2004A (expiration 9/9/2022). The product was manufactured by Nephron Sterile Compounding Center LLC, a 503B outsourcing facility located at 4500 12th St. Extension, West Columbia, SC 29172. The product's NDC number is 69374-559-30.
A lack of assured sterility in an injectable medication is a serious concern because contaminated products could cause serious infections or other adverse health effects. The FDA classified this recall as Class II. No illnesses have been reported to date in connection with this product.
The recalled product
- Product
- HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-30
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable
- Hazard
- non-sterile
- contamination-risk
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)
- Lots: HN2001A
- Exp. 7/23/2022
- HN2003A
- Exp. 8/19/2022
- HN2004A
- Exp. 9/9/2022
Distribution
Distributed nationwide across the United States.
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