Diphenhydramine (Brookfield) – Incorrect Solvent (2014)
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
Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Brand
Brookfield Prescription Center Inc. dba MD Custom Rx
Lot Codes / Batch Numbers
Lot # / Beyond Use Date: 05012014@36 / 05/15/14
Products Sold
Lot # / Beyond Use Date: 05012014@36 / 05/15/14
Brookfield Prescription Center Inc. dba MD Custom Rx is recalling Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W due to Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.. 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/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
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
WI
Page updated: Jan 10, 2026