Midazolam Syrup (Safecor) – Foreign Substance Detected (2015)
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 HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.
Brand
Safecor Health, LLC
Lot Codes / Batch Numbers
Lot: 932333, Exp 08/04/16
Products Sold
Lot: 932333, Exp 08/04/16
Safecor Health, LLC is recalling Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box conta due to Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.. 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
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
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
NY
Page updated: Jan 7, 2026