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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 981–1000 of 1,000 recalls

Class IIITerminated

Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;

Apotex Scientific, Inc

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

January 26, 2016 · DrugView details →

Class IIITerminated

Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.

Apotex Scientific, Inc

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

January 26, 2016 · DrugView details →

Class IIITerminated

Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.

Bausch & Lomb, Inc.

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

January 18, 2016 · DrugView details →

Class IIITerminated

Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.

Bausch & Lomb, Inc.

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

January 18, 2016 · DrugView details →

Class IIITerminated

Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.

Bausch & Lomb, Inc.

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

January 18, 2016 · DrugView details →

Class IIITerminated

Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL

Virtus Pharmaceuticals, Llc

Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).

January 15, 2016 · DrugView details →

Class IIITerminated

risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.

Zydus Pharmaceuticals USA Inc

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

January 14, 2016 · DrugView details →

Class IIITerminated

NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61

Pharmedium Services, LLC

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

December 31, 2015 · DrugView details →

Class IIITerminated

NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61

Pharmedium Services, LLC

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

December 31, 2015 · DrugView details →

Class IIITerminated

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540

Sandoz Inc

Failed Impurities/Degradation Specifications; 9 month stability timepoint

December 31, 2015 · DrugView details →

Class IIITerminated

Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01

National Vitamin Co Inc

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

December 18, 2015 · DrugView details →

Class IIITerminated

VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305

Virtus Pharmaceuticals, Llc

Defective Delivery System: Product may contain leaking capsules.

December 17, 2015 · DrugView details →

Class IIITerminated

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51

Bio-pharm, Inc.

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

December 17, 2015 · DrugView details →

Class IIITerminated

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

Morton Grove Pharmaceuticals, Inc.

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

December 15, 2015 · DrugView details →

Class IIITerminated

Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1

Genzyme Corporation

Labeling: Incorrect or Missing Lot and/or Exp Date

December 8, 2015 · DrugView details →

Class IIITerminated

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

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications; Impurity A

December 7, 2015 · DrugView details →

Class IIITerminated

Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017.

Pfizer Inc.

Failed Dissolution Specification

December 2, 2015 · DrugView details →

Class IIITerminated

MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.

Golden State Medical Supply Inc.

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

November 25, 2015 · DrugView details →

Class IIITerminated

MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10.

Golden State Medical Supply Inc.

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

November 25, 2015 · DrugView details →

Class IIITerminated

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

Teva Pharmaceuticals USA

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

November 19, 2015 · DrugView details →

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