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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 641–660 of 1,000 recalls

Class IIITerminated

Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05

Akorn, Inc.

Failed Stability Specification: OOS low viscosity results discovered during retain testing.

February 21, 2018 · DrugView details →

Class IIITerminated

Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01

LEADIANT BIOSCIENCES, INC

Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.

February 14, 2018 · DrugView details →

Class IIITerminated

Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02

Nostrum Laboratories Inc

Presence of Foreign Tablets/Capsules

February 13, 2018 · DrugView details →

Class IIITerminated

BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74

Webrx dba RxPalace.com

CGMP Deviations: not manufactured according to current good manufacturing practices.

February 7, 2018 · DrugView details →

Class IIITerminated

Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01

Genentech, Inc.

Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.

February 5, 2018 · DrugView details →

Class IIITerminated

Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol - 389 350, Gujarat, India --- NDC 47335-779-91

Sun Pharmaceutical Industries, Inc.

Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station

February 5, 2018 · DrugView details →

Class IIITerminated

Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56

Teva Pharmaceuticals USA

Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.

February 5, 2018 · DrugView details →

Class IIITerminated

Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.

Aurobindo Pharma Ltd.

Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg

February 2, 2018 · DrugView details →

Class IIITerminated

NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.

ALLERGAN

Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.

February 2, 2018 · DrugView details →

Class IIITerminated

Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

January 29, 2018 · DrugView details →

Class IIITerminated

Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

January 29, 2018 · DrugView details →

Class IIITerminated

Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

January 29, 2018 · DrugView details →

Class IIITerminated

Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

January 29, 2018 · DrugView details →

Class IIITerminated

Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

January 29, 2018 · DrugView details →

Class IIITerminated

Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51

Mckesson Packaging Services

Subpotent Drug: Out of specification for assay (stability testing)

January 29, 2018 · DrugView details →

Class IIITerminated

Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

January 29, 2018 · DrugView details →

Class IIITerminated

Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

January 29, 2018 · DrugView details →

Class IIITerminated

Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205

JCB Laboratories LLC

Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.

January 24, 2018 · DrugView details →

Class IIITerminated

Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W8, UPC 057800062653

Oxygen Development Llc

Superpotent drug: failed assay throughout the stick after 6 months stability.

January 24, 2018 · DrugView details →

Class IIITerminated

Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01

Ascent Pharmaceuticals, Inc.

Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol

January 22, 2018 · DrugView details →

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