Diphenhydramine Injectable (Franck's Lab) – sterility risk (2012)
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 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100 ML, 108 ML, 120 MLS, 25 ML, 32 ML, 60 ML, 90 ML, 90 MLS; DIPHENHYDRAMINE, SDV, 25X1ML** 50MG/ML INJECTABLE 25 ML (11 DIFFERENT PRODUCTS)
Brand
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Rx #'s: 0387528 0395197 0389191 0390909 0406810 0409865 0388591 0388594 0388595 0388597 0388598 0388599 0388602 0388604 0391126 0390909 0390909 0397860 0400856 0402992 0404849 0406843
Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100 ML, 108 ML, due to Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because . 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: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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