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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 921–940 of 1,000 recalls

Class IIITerminated

Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41

West-Ward Columbus Inc

Failed Impurities/Degradation Specification; 9 month stability

May 19, 2016 · DrugView details →

Class IIITerminated

Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada

Attix Pharmaceuticals Inc

cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration

May 18, 2016 · DrugView details →

Class IIITerminated

Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.

Teva North America

Failed Tablet/Capsule Specifications

May 18, 2016 · DrugView details →

Class IIITerminated

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47479-9, Shade 04 (M-N)

Clinique International

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

May 17, 2016 · DrugView details →

Class IIITerminated

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N)

Clinique International

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

May 17, 2016 · DrugView details →

Class IIITerminated

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48241-1, Shade 06 (D-G)

Clinique International

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

May 17, 2016 · DrugView details →

Class IIITerminated

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48240-4, Shade 05 (D-G)

Clinique International

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

May 17, 2016 · DrugView details →

Class IIITerminated

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47477-5, Shade 02 (VF-N)

Clinique International

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

May 17, 2016 · DrugView details →

Class IIITerminated

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N)

Clinique International

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

May 17, 2016 · DrugView details →

Class IIITerminated

VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30

Virtus Pharmaceuticals, Llc

Defective delivery system: Softgel capsules are leaking.

May 16, 2016 · DrugView details →

Class IIITerminated

PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY

Medaus, Inc.

Lack of Assurance of Sterility

May 13, 2016 · DrugView details →

Class IIITerminated

Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10

Virtus Pharmaceuticals, Llc

Chemical Contamination: Bottles may contain broken dessicants

May 13, 2016 · DrugView details →

Class IIITerminated

Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03

KVK-Tech, Inc.

Discoloration: presence of scuffing marks on tablets.

May 5, 2016 · DrugView details →

Class IIITerminated

Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01

Sandoz, Inc

Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.

May 2, 2016 · DrugView details →

Class IIITerminated

Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01

Sandoz, Inc

Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.

May 2, 2016 · DrugView details →

Class IIITerminated

Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1

Genzyme Corporation / Genzyme Biosurgery

Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.

April 27, 2016 · DrugView details →

Class IIITerminated

CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523

Dr. Reddy's Laboratories, Inc.

Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.

April 22, 2016 · DrugView details →

Class IIITerminated

Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0

A-S Medication Solutions LLC.

Labeling: Not elsewhere classified - count on the label was incorrect.

April 22, 2016 · DrugView details →

Class IIITerminated

SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.

Mckesson Packaging Services

Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.

April 12, 2016 · DrugView details →

Class IIITerminated

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.

Jubilant Cadista Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

April 8, 2016 · DrugView details →

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