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 14781–14800 of 17,832 recalls

Class IITerminated

Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30

Daiichi Sankyo Pharma Development

Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

July 12, 2014 · DrugView details →

Class ITerminated

0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043.

Baxter Healthcare Corp.

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

July 11, 2014 · DrugView details →

Class ITerminated

Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.

Baxter Healthcare Corp.

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics

July 11, 2014 · DrugView details →

Class ITerminated

0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

Baxter Healthcare Corp.

Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.

July 11, 2014 · DrugView details →

Class IITerminated

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90

Jubilant Cadista Pharmaceuticals Inc.

Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.

July 11, 2014 · DrugView details →

Class IIITerminated

Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.

Sandoz Inc

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

July 11, 2014 · DrugView details →

Class ITerminated

LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09

Hospira Inc.

Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.

July 10, 2014 · DrugView details →

Class IITerminated

Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01

Gyma Laboratories Of Amer,Inc

cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

July 9, 2014 · DrugView details →

Class IITerminated

Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004

Gyma Laboratories Of Amer,Inc

cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

July 9, 2014 · DrugView details →

Class IITerminated

Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084

Gyma Laboratories Of Amer,Inc

cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

July 9, 2014 · DrugView details →

Class IITerminated

Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002

Gyma Laboratories Of Amer,Inc

cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

July 9, 2014 · DrugView details →

Class IIITerminated

VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70

Pfizer Inc.

Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.

July 8, 2014 · DrugView details →

Class IIITerminated

Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.

Fougera Pharmaceuticals Inc.

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

July 3, 2014 · DrugView details →

Class IIITerminated

Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

July 3, 2014 · DrugView details →

Class IIITerminated

Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.

Fougera Pharmaceuticals Inc.

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

July 3, 2014 · DrugView details →

Class IITerminated

Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.

Mylan Pharmaceuticals Inc.

Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol

July 3, 2014 · DrugView details →

Class IIITerminated

E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.

Bracco Diagnostic Inc

Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.

July 2, 2014 · DrugView details →

Class ITerminated

Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01

American Health Packaging

Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544

July 1, 2014 · DrugView details →

Class ITerminated

Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 62584-143-01

American Health Packaging

Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544.

July 1, 2014 · DrugView details →

Class IITerminated

fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8015-04

Healix Infusion Therapy, Inc.

Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

June 27, 2014 · DrugView details →

← PreviousPage 740 of 892Next →