FDA Drug Recalls

1,463 recalls · Class I, newest first

Class I · High risk Terminated Dec 9, 2015

Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight…

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

Lucy's Weight Loss (dba. Waisted With Lucy) D-0882-2016

Class I · High risk Terminated Dec 3, 2015

LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238…

Reason Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite…

Lipo Escultura Corp. D-0860-2016

Class I · High risk Terminated Nov 23, 2015

SUPER HERBS 350 mg, 30 capsules per bottle.

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

Super Herbs D-0909-2016

Class I · High risk Terminated Oct 28, 2015

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b)…

Reason Defective Delivery System; potential to have inaccurate dosage delivery

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

Class I · High risk Terminated Oct 28, 2015

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1…

Reason Defective Delivery System; potential to have inaccurate dosage delivery

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

Class I · High risk Terminated Oct 5, 2015

NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056…

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

Inaffit, LLC D-0675-2016

Class I · High risk Terminated Oct 1, 2015

Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA

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

MSNV, Inc dba National Video Supply D-0671-2016

Class I · High risk Terminated Oct 1, 2015

Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA.

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

MSNV, Inc dba National Video Supply D-0670-2016

Class I · High risk Terminated Sep 30, 2015

Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA

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

Premiere Sales Group D-0673-2016

Class I · High risk Terminated Sep 30, 2015

Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA

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

Premiere Sales Group D-0672-2016

Class I · High risk Terminated Sep 29, 2015

Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 of 3, fit firm & fabulous, UPC 5 42423 25422 1.

Reason Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously…

Fit Firm and Fabulous D-0722-2016

Class I · High risk Terminated Sep 25, 2015

Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA, UPC 700729253748

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

Tf Supplements D-0772-2016

Class I · High risk Terminated Sep 25, 2015

RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA

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

Tf Supplements D-0771-2016

Class I · High risk Terminated Sep 25, 2015

ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc…

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

Medline Industries Inc NDC 53329-642-30 D-0663-2016

Class I · High risk Terminated Sep 25, 2015

ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein…

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

Medline Industries Inc NDC 53329-641-30 D-0662-2016

Class I · High risk Terminated Sep 23, 2015

Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by…

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

Lucy's Weight Loss (dba. Waisted With Lucy) D-0881-2016

Class I · High risk Terminated Sep 23, 2015

Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and…

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

Lucy's Weight Loss (dba. Waisted With Lucy) D-0880-2016

Class I · High risk Terminated Sep 23, 2015

Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight…

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

Lucy's Weight Loss (dba. Waisted With Lucy) D-0879-2016

Class I · High risk Terminated Aug 24, 2015