FDA Drug Recalls

526 recalls, newest first

Nov 23, 2015 Class I · High risk

SUPER HERBS 350 mg

Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.

Terminated Chemical / undeclared Super Herbs D-0909-2016

Oct 5, 2015 Class I · High risk

Natureal Burn Fat Nature

Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.

Terminated Chemical / undeclared Inaffit, LLC D-0675-2016

Oct 1, 2015 Class I · High risk

Rhino 7 Platinum 3000

Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.

Terminated Chemical / undeclared MSNV, Inc dba National Video Supply D-0671-2016

Oct 1, 2015 Class I · High risk

Rhino 7 3000

Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.

Terminated Chemical / undeclared MSNV, Inc dba National Video Supply D-0670-2016

Oct 1, 2015 Class III · Low risk

Fenofibric Acid Tablets 105 mg

Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.

Terminated Chemical / undeclared Tribute Pharmaceuticals US Inc. NDC 13310-102-07 D-0017-2016

Oct 1, 2015 Class III · Low risk

Fenofibric Acid Tablets

Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.

Terminated Chemical / undeclared Tribute Pharmaceuticals US Inc. NDC 13310-101-07 D-0016-2016

Sep 30, 2015 Class I · High risk

Rhino 7 Platinum 3000

Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.

Terminated Chemical / undeclared Premiere Sales Group D-0673-2016

Sep 30, 2015 Class I · High risk

Rhino 7 3000

Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.

Terminated Chemical / undeclared Premiere Sales Group D-0672-2016

Sep 29, 2015 Class I · High risk

Ultimate Herbal Slimcap Capsules

Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.

Terminated Chemical / undeclared Fit Firm and Fabulous D-0722-2016

Sep 25, 2015 Class I · High risk

Rhino 7 Platinum 3000

Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.

Terminated Chemical / undeclared Tf Supplements D-0772-2016

Sep 25, 2015 Class I · High risk

Rhino 7 3000

Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.

Terminated Chemical / undeclared Tf Supplements D-0771-2016

Sep 23, 2015 Class I · High risk

Shorts on The Beach Golden Edition by Pink Bikini

Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.

Terminated Chemical / undeclared Lucy's Weight Loss (dba. Waisted With Lucy) D-0881-2016

Sep 23, 2015 Class I · High risk

Shorts on The Beach Strong Formula by Pink Bikini capsules

Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.

Terminated Chemical / undeclared Lucy's Weight Loss (dba. Waisted With Lucy) D-0880-2016

Sep 23, 2015 Class I · High risk

Pink Bikini Strong Formula capsules

Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.

Terminated Chemical / undeclared Lucy's Weight Loss (dba. Waisted With Lucy) D-0879-2016

Sep 10, 2015 Class III · Low risk

ClomiPHENE CITRATE Tablets

Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.

Terminated Chemical / undeclared EMD Serono, Inc. NDC 0093-0041-03 D-1813-2015

Sep 4, 2015 Class II · Moderate risk

Surgicept (Ethyl alcohol 70% w/w)

Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.

Terminated Chemical / undeclared Healthpoint, Ltd D-1427-2015

Aug 6, 2015 Class II · Moderate risk

DuraPrep Surgical Solution Iodine Povacrylex

Chemical contamination: Product may be contaminated with a toxic compound.

Terminated Chemical / undeclared 3M Company - Health Care Business NDC 17518-0011-08 D-1417-2015

Aug 6, 2015 Class I · High risk

KABOOM action strips

Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.

Terminated Chemical / undeclared Blue Square Market, Inc. D-0297-2016

Aug 6, 2015 Class I · High risk

LiDa DAIDAIHUA

Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.

Terminated Chemical / undeclared Blue Square Market, Inc. D-0296-2016

Jul 16, 2015 Class III · Low risk