Class I · High risk
The Medical Center of Aurora
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
FDA drug recalls in 2014
Every FDA drug recall initiated in 2014, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,309 recalls, newest first.
Class I · High risk
Rose Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Rose Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Children's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
University of Alabama Birmingham TPN Neonatal Starter Bag
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class II · Moderate risk
Entertainer's Secret Throat Relief
Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
Class II · Moderate risk
Alprazolam tablets
Subpotent Drug
Class II · Moderate risk
J-TAN D PD Drops
Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Class II · Moderate risk
Gabapentin Capsules
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Class II · Moderate risk
Gabapentin Capsules
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Class II · Moderate risk
Gabapentin Capsules
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Class I · High risk
Professional Formexx Black
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
Swoll-250 Super Mass Builder Quad Stack
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
Estrastain Pro-Anabolic Mass and Hardening Complex
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
7-Ment Alpha Advanced Mass Builder
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
Halo-70 Mega Mass Builder
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
M14-Ment Advanced Mass Builder
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class I · High risk
M1-Alpha Labs Mega Mass Builder
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Class II · Moderate risk
Hydroxocobalamin Injection Solution 1 mg/mL Inj.
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Class II · Moderate risk
Glutathione 200 mg/mL Injectable
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
Class III · Low risk
Triamcinolone Acetonide Lotion USP
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
Class III · Low risk
sulfur8
Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.
Class III · Low risk
BELVIQ¿ (Lorcaserin HCl)
Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.
Class III · Low risk
Fluoxetine Capsules USP
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.