FDA Drug Recalls

1,463 recalls · Class I, newest first

Dec 9, 2015 Class I · High risk

Pink Bikini capsules

Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.

Terminated Chemical / undeclared Lucy's Weight Loss (dba. Waisted With Lucy) D-0882-2016

Dec 3, 2015 Class I · High risk

Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.

Terminated Chemical / undeclared Lipo Escultura Corp. D-0860-2016

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 28, 2015 Class I · High risk

Auvi-Q (epinephrine injection, USP)

Defective Delivery System; potential to have inaccurate dosage delivery

Terminated Packaging defect Sanofi-Aventis U.S. LLC NDC 0024-5831-02 D-0873-2016

Oct 28, 2015 Class I · High risk

Auvi-Q (epinephrine injection, USP)

Defective Delivery System; potential to have inaccurate dosage delivery

Terminated Packaging defect Sanofi-Aventis U.S. LLC NDC 0025-5833-02 D-0872-2016

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

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 25, 2015 Class I · High risk

ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets

Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.

Terminated Labeling / mix-up Medline Industries Inc NDC 53329-642-30 D-0663-2016

Sep 25, 2015 Class I · High risk

ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets

Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.

Terminated Labeling / mix-up Medline Industries Inc NDC 53329-641-30 D-0662-2016

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