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.
FDA Drug Recalls
14,806 recalls, newest first
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.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk
Eye Drops Advanced Relief
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk
Eye Drops Industrial Strength
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk
Eye Drops A.C.
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Class III · Low risk
Eye Drops (Tetrahydrozoline HCl 0.05%)
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.