FDA Recalls USDA Recalls About

FDA Recalls

Food recalls
Drug recalls
Device recalls

USDA Recalls

All USDA recalls
Poultry recalls
Meat recalls
Egg recalls

About

About us
FDA guides
USDA guides
Data sources
Privacy policy

Data

OpenFDA API
USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

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 11821–11840 of 17,816 recalls

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 IITerminated

Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87

Baxter Healthcare Corp.

Discoloration: presence of atypical yellow discoloration of the solution .

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 →

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 IITerminated

Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-0404-00.

Akorn, Inc.

Presence of Particulate Matter

April 7, 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 IITerminated

Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10

Fresenius Kabi USA, LLC

Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.

April 5, 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 IITerminated

BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.

Keystone Laboratories Inc

Microbial Contamination of Non-Sterile Products: Failed S.aureus test.

April 4, 2016 · DrugView details →

Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014

Complete Pharmacy and Medical Solutions LLC

Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.

April 2, 2016 · DrugView details →

Class IIOngoing

LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL

Invisiblu International LLC

Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033

March 31, 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 ITerminated

PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35.

QuVa Pharma, Inc.

Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.

March 30, 2016 · DrugView details →

Class IITerminated

Ondansetron Tablets USP, 4 mg, 30 count bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories, Bachupally, India --- NDC 56111-153-30

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications; 12 month stability time point

March 30, 2016 · DrugView details →

← PreviousPage 592 of 891Next →