FDA Drug Recalls

1,709 recalls · Class III, newest first

Class III · Low risk Terminated Jan 14, 2016

risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad…

Reason Failed Impurities/Degradation Specifications: Out of specification for a known degradant.

Zydus Pharmaceuticals USA Inc D-0725-2016

Class III · Low risk Terminated Dec 31, 2015

NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx…

Reason Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

Pharmedium Services, LLC NDC 61553-127-61 D-0778-2016

Class III · Low risk Terminated Dec 31, 2015

NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only…

Reason Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

Pharmedium Services, LLC NDC 61553-134-61 D-0777-2016

Class III · Low risk Terminated Dec 31, 2015

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only…

Reason Failed Impurities/Degradation Specifications; 9 month stability timepoint

Sandoz Inc NDC 00781-5938-31 D-0659-2016

Class III · Low risk Terminated Dec 18, 2015

Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and…

Reason Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.

National Vitamin Co Inc NDC 54629-0640-01 D-0568-2016

Class III · Low risk Terminated Dec 17, 2015

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage…

Reason Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.

Bio-pharm, Inc. NDC 23155-291-51 D-0809-2016

Class III · Low risk Terminated Dec 17, 2015

VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured…

Reason Defective Delivery System: Product may contain leaking capsules.

Virtus Pharmaceuticals, Llc NDC 69543-224-30 D-0801-2016

Class III · Low risk Terminated Dec 15, 2015

Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60

Reason Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.

Morton Grove Pharmaceuticals, Inc. NDC 60432-833-60 D-0571-2016

Class III · Low risk Terminated Dec 8, 2015

Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

Genzyme Corporation NDC 58468-0160-1 D-0799-2016

Class III · Low risk Terminated Dec 7, 2015

Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09

Reason Failed Impurities/Degradation Specifications; Impurity A

Lupin Pharmaceuticals Inc. NDC 68180-556-09 D-0650-2017

Class III · Low risk Terminated Dec 2, 2015

Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31)…

Reason Failed Dissolution Specification

Pfizer Inc. NDC 0025-2742-31 D-0520-2016

Class III · Low risk Terminated Nov 25, 2015

MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.

Golden State Medical Supply Inc. D-0510-2016

Class III · Low risk Terminated Nov 25, 2015

MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.

Golden State Medical Supply Inc. D-0509-2016

Class III · Low risk Terminated Nov 19, 2015

NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL

Reason Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.

Teva Pharmaceuticals USA D-0773-2016

Class III · Low risk Terminated Nov 10, 2015

Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By…

Reason Labeling: Not elsewhere classified. NDC number is incorrect on the container.

Northwind Pharmaceuticals LLC NDC 51655-320-53 D-0485-2016

Class III · Low risk Terminated Nov 4, 2015

Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC…

Reason Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

Dr. Reddy's Laboratories, Inc. NDC 55111-665-30 D-0721-2016

Class III · Low risk Terminated Nov 4, 2015

Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC…

Reason Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

Dr. Reddy's Laboratories, Inc. NDC 55111-664-30 D-0720-2016

Class III · Low risk Terminated Nov 4, 2015

Paricalcitol Capsules, 1 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC…

Reason Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

Dr. Reddy's Laboratories, Inc. NDC 55111-663-30 D-0719-2016

Class III · Low risk Terminated Nov 2, 2015

Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) D-0235-2016

Class III · Low risk Terminated Oct 30, 2015

Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway…

Reason Failed Impurities/Degradation Specifications: Out of specifications results for impurities.

Avantor Performance Materials Inc D-0563-2016

Class III · Low risk Terminated Oct 29, 2015

EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840…

Reason Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).

PQ Corporation D-0564-2016

Class III · Low risk Terminated Oct 26, 2015

Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.

Par Pharmaceutical Inc. D-0234-2016

Class III · Low risk Terminated Oct 26, 2015

Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles…

Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.

Par Pharmaceutical Inc. D-0233-2016

Class III · Low risk Terminated Oct 21, 2015

Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A…

Reason Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle

Breckenridge Pharmaceutical, Inc D-0181-2016

Class III · Low risk Terminated Oct 21, 2015

RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST…

Reason Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals D-0162-2016