Midazolam Sodium Chloride Injection (SterRx) – Sterility Concerns (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
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
Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02.
Brand
SterRx, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
S21065/BQA 12-Nov-21 S21066/BQB 19-Nov-21 S21142/BTA 19-Nov-21 S21143/BTB 20-Nov-21 S21146/BTE 21-Nov-21 S21147/BTF 25-Nov-21 S21148/BTG 25-Nov-21 S21153/BTL 26-Nov-21 S21154/BTM 27-Nov-21 S21171/BUC 10-Dec-21 S21172/BUD 11-Dec-21 S21173/BUE 15-Dec-21 S21190/BUT 16-Dec-21 S21201/BVD 22-Dec-21 S21202/BVE 24-Dec-21 S21203/BVF 29-Dec-21 S21204/BVG 19-Jan-22 S21258/BXD 20-Jan-22 S21275/BXS 30-Jan-22 S21276/BXT 2-Feb-22 S21277/BXU 3-Feb-22 S21278/BXV 3-Feb-22 S21284/BYB 4-Feb-22 S21285/BYC 5-Feb-22 S21286/BYD 11-Feb-22 S21287/BYE 12-Feb-22 S21290/BYH 16-Feb-22 S21304/BYT 23-Feb-22 S21306/BYV 24-Feb-22 S21308/BYX 25-Feb-22 S21310/BYZ 26-Feb-22 S21379/CBM 14-Apr-22 S21382/CBP 14-Apr-22 S21385/CBS 15-Apr-22
SterRx, LLC is recalling Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 I due to Lack of Assurance of Sterility. 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
Lack of Assurance of Sterility
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