FDA Drug recall D-1503-2012

DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML

FDA Drug
Class II
terminated
Published 2012-08-22

On 2012-08-22 the FDA classified a Class II recall of DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML by Franck S Lab D B A Franck S Compounding Lab, citing 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 re….

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1503-2012
Classification	Class II
Status	terminated
Initiated	2012-05-25
Published	2012-08-22
Last updated	2026-09-13 11:51 UTC
Company	Franck S Lab D B A Franck S Compounding Lab
Distribution	US

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)

Reason

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.

Identifiers

code_info	Rx #'s: 0387528 0395197 0389191 0390909 0406810 0409865 0388591 0388594 0388595 0388597… Rx #'s: 0387528 0395197 0389191 0390909 0406810 0409865 0388591 0388594 0388595 0388597 0388598 0388599 0388602 0388604 0391126 0390909 0390909 0397860 0400856 0402992 0404849 0406843

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1503-2012%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.