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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 941–960 of 1,000 recalls

Class IIITerminated

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), 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 →

Class IIITerminated

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), 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 →

Class IIITerminated

Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.

Fresenius Kabi USA, LLC

Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.

April 7, 2016 · DrugView details →

Class IIITerminated

Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.

Lupin Pharmaceuticals Inc.

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

April 6, 2016 · DrugView details →

Class IIITerminated

Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.

Lupin Pharmaceuticals Inc.

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

April 6, 2016 · DrugView details →

Class IIITerminated

Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30

Lupin Pharmaceuticals Inc.

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

April 4, 2016 · DrugView details →

Class IIITerminated

Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.

Amerisource Health Services

Labeling: Incorrect or Missing Lot and/or Exp Date

March 31, 2016 · DrugView details →

Class IIITerminated

Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.

Amerisource Health Services

Labeling: Incorrect or Missing Lot and/or Exp Date

March 31, 2016 · DrugView details →

Class IIITerminated

Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.

Purdue Pharma L.P.

Failed Dissolution Specifications

March 31, 2016 · DrugView details →

Class IIITerminated

¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-5205-5.

Taro Pharmaceuticals U.S.A., Inc.

Subpotent Drug

March 31, 2016 · DrugView details →

Class IIITerminated

Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.

Bryant Ranch Prepack Inc.

Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.

March 25, 2016 · DrugView details →

Class IIITerminated

Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.

AbbVie Inc.

Failed Content Uniformity Specifications

March 24, 2016 · DrugView details →

Class IIITerminated

Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01

Lupin Limited

Labeling: Incorrect or Missing Lot and/or Expiration Date

March 24, 2016 · DrugView details →

Class IIITerminated

Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134

Biocon Inc

Subpotent Drug

March 24, 2016 · DrugView details →

Class IIITerminated

Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02

Impax Laboratories, Inc.

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

March 17, 2016 · DrugView details →

Class IIITerminated

Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02

Impax Laboratories, Inc.

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

March 17, 2016 · DrugView details →

Class IIITerminated

Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10

Actavis Pharma Inc

Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).

March 16, 2016 · DrugView details →

Class IIITerminated

Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.

Lupin Pharmaceuticals Inc.

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

March 11, 2016 · DrugView details →

Class IIITerminated

Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

Lupin Pharmaceuticals Inc.

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

March 11, 2016 · DrugView details →

Class IIITerminated

SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05

Jubilant Draximage Inc

Labeling: Label Error on Declared Strength

March 11, 2016 · DrugView details →

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