Hydromorphone HCl 1 mg/mL 250 mL Bags Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling four bags of Hydromorphone HCl 1 mg/mL (250 mL each) distributed in North Carolina due to lack of assurance of sterility. The affected lots have beyond-use dates of October 25–30, 2020.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. Lack of sterility assurance in injectable medications creates a direct risk of infection, which is a serious health hazard. Although no illnesses have been reported in the source text, the hazard nature (injectable contamination risk) and the Class II classification together warrant a Severe rating.
Plain-English summary
Family Pharmacy of Statesville, Inc. is recalling Hydromorphone HCl 1 mg/mL 250 mL bags (Rx only) because the manufacturer cannot assure sterility of the product. The recall involves four bags with lot numbers 07272020@2, 07302020@1, and 08012020@1, with beyond-use dates of October 25, 28, and 30, 2020, respectively.
The affected product was distributed in North Carolina only. Hydromorphone is a prescription opioid medication. Lack of sterility assurance in injectable medications poses a risk of infection if the product is used.
Patients or healthcare providers in possession of the affected lots should not use this medication and should contact their pharmacy. Patients should consult with their healthcare provider about obtaining a replacement prescription if needed.
The recalled product
- Product
- Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- Category
- Drug — Injectable / Opioid
- Hazard
- sterility-assurance
- injectable-contamination
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 (3)
- Lot #: 07272020@2 BUD: 10/25/2020
- 07302020@1 BUD: 10/28/2020
- 08012020@1 BUD: 10/30/2020
Distribution
Distributed in 1 state:
- NC
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27