Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
All Recalls
95,064 total recalls in our database
My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container. UPC# 0-70934-99645-8
The Mochi Ice Cream Company
Foreign object found inside retail container.
Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UPC 0 79581-18709 7. Keep Refrigerated After Opening. King Juice Company, Inc., Milwaukee, Wisconsin 53221.
King Juice Company
Product contains undeclared Yellow No. 5.
KLG, Kesar Mukhwas, perishable, 24 months, flexible plastic, 200 gm, 818812022208, Ganesha Enterprises LLC, 5200 Sigstrom Drive, Carson City, Nevada 89706 USA.
Ganesha Enterprises
Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14.
product tested positive for Listeria Monocytogenes.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Wells Pharma of Houston
cGMP deviations.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
Wells Pharma of Houston
cGMP deviations.
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
Wells Pharma of Houston
cGMP deviations.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.
Hikma Pharmaceuticals USA
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
Wells Pharma of Houston
cGMP deviations.
Lack of Assurance of Sterility
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
Wells Pharma of Houston
cGMP deviations.
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950
Water-Jel Technologies
Failed PH Specifications
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Wells Pharma of Houston
cGMP deviations.
Labeling: Missing Label
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
Wells Pharma of Houston
cGMP deviations.