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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 10,361–10,380 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-241-03

by PharMEDium Services, LLC

Reason
Subpotent Drug
Recall initiated
September 1, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only , Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130, Sugar Land, TX 77478, NDC# 71019-237-01

by PharMEDium Services, LLC

Reason
Subpotent Drug
Recall initiated
September 1, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30

by AbbVie Inc.

Reason
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Recall initiated
September 8, 2017
Reported by FDA
November 1, 2017
Distribution
AZ

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Drug Recall Terminated Historical recordClass I

MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; vitility@yahoo.com; www.manofsteelpills.com; UPC 1 0001001378 7.

by Vitility

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Recall initiated
June 22, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, Manufactured By: Jimin Pharmaceutial Co., LTD., Distributor: Lucky Mart, El Monte, CA 91733, NDC 68085-8012-4.

by Lucky Mart Inc.

Reason
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Recall initiated
August 29, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025014801

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

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Drug Recall Terminated Historical recordClass II

VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025007001

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025001001.

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601

by Banner Pharmacy Services, LLC

Reason
Lack of Assurance of Sterility.
Recall initiated
October 10, 2017
Reported by FDA
November 1, 2017
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.

by The Harvard Drug Group

Reason
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Recall initiated
September 26, 2017
Reported by FDA
October 25, 2017
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10

by RXQ Compounding LLC

Reason
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Recall initiated
September 25, 2017
Reported by FDA
October 25, 2017
Distribution
TX, LA, PA, MA, FL, and OH

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Drug Recall Terminated Historical recordClass II

Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in the US b: Biological Health Group Corp. Bremerton, WA 98337. NDC 69711-125-61

by Deserving Health International Corp

Reason
Lack of Assurance of Sterility
Recall initiated
September 20, 2017
Reported by FDA
October 25, 2017
Distribution
Product was distributed throughout the United States.

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Drug Recall Terminated Historical recordClass II

Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13.

by UNICHEM PHARMACEUTICALS USA INC

Reason
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Recall initiated
October 2, 2017
Reported by FDA
October 25, 2017
Distribution
Product was distributed nationwide

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Drug Recall Terminated Historical recordClass III

Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India

by Dr. Reddy's Laboratories, Inc.

Reason
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
Recall initiated
October 3, 2017
Reported by FDA
October 18, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417

by United Pharmacy

Reason
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Recall initiated
September 27, 2017
Reported by FDA
October 18, 2017
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01

by Boehringer Ingelheim Pharmaceuticals, Inc.

Reason
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Recall initiated
September 22, 2017
Reported by FDA
October 18, 2017
Distribution
CO, OH

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Drug Recall Terminated Historical recordClass III

Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in 10 fl. oz ( 296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 6984238038, UPC 050428418321, b) Meijer, Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544, NDC 4125038038, UPC 708820824294, c) Life Brand, Manufactured for: Shoppers Drug Mark/Pharmaprix Toronto, UPC 057800856405

by Vi-Jon, Inc.

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
September 13, 2017
Reported by FDA
October 11, 2017
Distribution
United States and Canada

View recall →

Drug Recall Terminated Historical recordClass III

Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 59779-667-38, UPC 05042842790; b) Swan Citroma, Distributed by: Vi-Jon One Swan Drive Smyrna, TN 37167, NDC 0869066738, UPC 308690667382; c) GoodSense, Distributed By: Geiss, Destin & Dunn, Inc. Peachtree City, GA 30269, NDC 50804-667-38, UPC 846036007374; d) Leader, Distributed By: Cardinal Health, Dublin, Ohio, 43017, NDC 3720511038, UPC 096295382433; e) Signature Care, Distributed By: Better Living Brands, LLC. P.O. Box 99, Pleasanton, CA 94566-0009, NDC 21130-667-38, UPC 321130779155; f) Discount Drug Mart Food Fair, Distributed By: Drug Mart-Food Fair Medina, Ohio 44256, NDC 5394301077, UPC 093351100383; g) Sunmark, Distributed By McKesson One Post Street San Francisco, CA 94104, NDC 4934869649, UPC 010939112330, h) Major, Distributed By: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA, NDC 0904630477, UPC 309046304777

by Vi-Jon, Inc.

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
September 13, 2017
Reported by FDA
October 11, 2017
Distribution
United States and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ

by Inopak Ltd

Reason
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Recall initiated
August 23, 2017
Reported by FDA
October 11, 2017
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopak. Ltd, Ringwood, NJ 07456

by Inopak Ltd

Reason
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Recall initiated
August 23, 2017
Reported by FDA
October 11, 2017
Distribution
nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.