FDA Drug Recalls

1,739 recalls · Class I, newest first

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 Ongoing Aug 27, 2015

MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.

Reason Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in…

The One Minute Miracle Inc D-0230-2016

Class I · High risk Ongoing Aug 27, 2015

MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One…

Reason Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male…

The One Minute Miracle Inc D-0229-2016

Class I · High risk Terminated Aug 24, 2015