US Drug Recall Register

FDA Drug Recalls

1,739 recalls · Class I, newest first

Class I · High risk Terminated

Magic Slim capsules

Reason Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.

Slim Beauty USA D-1221-2014
Class I · High risk Terminated

Dr. Ming's Chinese Capsule

Reason Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.

Slim Beauty USA D-1220-2014
Class I · High risk Terminated

Hyperlyte CR

Reason Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc NDC 0264-1943-20 D-1275-2014
Class I · High risk Terminated

ProcalAmine

Reason Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc NDC 0264-1915-07 D-1274-2014
Class I · High risk Terminated

TrophAmine

Reason Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc NDC 0264-9341-55 D-1273-2014
Class I · High risk Terminated

15% Amino Acids Injection PBP Glass

Reason Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc NDC 0264-3200-55 D-1272-2014
Class I · High risk Terminated

6.9% FreAmine HBC

Reason Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc NDC 0264-9350-55 D-1271-2014
Class I · High risk Terminated

0.9 % Sodium Chloride Injection USP

Reason Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc NDC 0264-4000-55 D-1270-2014
Class I · High risk Terminated

Cefazolin for Injection USP and Dextrose Injection USP

Reason Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc NDC 0264-3105-11 D-1269-2014
Class I · High risk Terminated

Cefazolin for Injection USP and Dextrose Injections USP

Reason Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc NDC 0264-3103-11 D-1268-2014
Class I · High risk Terminated

Cefepime for Injections USP and Dextrose Injection USP

Reason Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc NDC 0264-3193-11 D-1267-2014
Class I · High risk Terminated

Ceftriaxone for Injection and Dextrose Injection

Reason Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc D-1266-2014
Class I · High risk Terminated

Cefoxitin for Injection and Dextrose Injection

Reason Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

B. Braun Medical Inc NDC 0264-3123-11 D-1264-2014
Class I · High risk Terminated

0.9% Sodium Chloride Injection

Reason Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Baxter Healthcare Corp. NDC 0338-0049-31 D-1163-2014
Class I · High risk Terminated

5% Dextrose Injection

Reason Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Baxter Healthcare Corp. NDC 0338-0017-38 D-1162-2014
Class I · High risk Terminated

vitaliKOR Ready When You Are

Reason Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules

Vitality Research Labs LLC D-1364-2014
Class I · High risk Terminated

NATURECT Capsules Dietary Supplement 500 mg

Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.

Tendex D-1346-2014
Class I · High risk Terminated

P-BOOST Capsules Dietary Supplement 500 mg

Reason Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.

Tendex D-1345-2014
Class I · High risk Terminated

RezzRX capsules

Reason Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.

Fossil Fuel Products, LLC D-1248-2014
Class I · High risk Terminated

Clinimix 5/15 sulfite-free

Reason Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Baxter Healthcare Corp. D-1160-2014
Class I · High risk Terminated

Clinimix E 4.25/10 sulfite-free

Reason Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Baxter Healthcare Corp. NDC 0338-1115-04 D-1159-2014
Class I · High risk Terminated

Clinimix 4.25/25 sulfite-free

Reason Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Baxter Healthcare Corp. D-1158-2014
Class I · High risk Terminated

50 mg Nitroglycerin in 5% Dextrose Injection

Reason Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.

Baxter Healthcare Corp. NDC 0338-1049-02 D-1057-2014
Class I · High risk Terminated

eXtenZone capsules

Reason Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b

SS Wholesale Inc. dba Jobbers Wholesale D-1047-2014