FDA Drug Recalls

14,801 recalls, newest first

Class II · Moderate risk Terminated Aug 13, 2015

Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf…

Reason Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.

Safecor Health, LLC D-0657-2016

Class III · Low risk Terminated Aug 11, 2015

METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged…

Reason Presence of Foreign Substance: Presence of hair.

Golden State Medical Supply Inc. D-1426-2015

Class II · Moderate risk Terminated Aug 6, 2015

DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin…

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

3M Company - Health Care Business NDC 17518-0011-08 D-1417-2015

Class I · High risk Terminated Aug 6, 2015

KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC

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

Blue Square Market, Inc. D-0297-2016

Class I · High risk Terminated Aug 6, 2015

LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali…

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

Blue Square Market, Inc. D-0296-2016

Class III · Low risk Terminated Aug 5, 2015

Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario…

Reason Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.

Taro Pharmaceuticals, Inc. D-1370-2015

Class II · Moderate risk Terminated Aug 3, 2015

Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 55111-352-60 D-1325-2015

Class II · Moderate risk Terminated Jul 30, 2015

Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind…

Reason Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.

Unichem Pharmaceuticals Usa Inc NDC 29300-128-10 D-1352-2015

Class II · Moderate risk Terminated Jul 29, 2015

Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only…

Reason Failed Dissolution Specifications

Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals NDC 0603-4214-60 D-1406-2015

Class II · Moderate risk Terminated Jul 29, 2015

Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by…

Reason CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Wockhardt Usa Inc. NDC 64679-941-06 D-1347-2015

Class II · Moderate risk Terminated Jul 29, 2015

Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by…

Reason CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Wockhardt Usa Inc. NDC 64679-928-06 D-1346-2015