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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 1,821–1,840 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

by Bestco LLC

Reason
CGMP Deviations: Potential Glass and Silicone particulates in product
Recall initiated
January 19, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

by Bestco LLC

Reason
CGMP Deviations: Potential Glass and Silicone particulates in product
Recall initiated
January 19, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

by Bestco LLC

Reason
CGMP Deviations: Potential Glass and Silicone particulates in product
Recall initiated
January 19, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115

by Bestco LLC

Reason
CGMP Deviations: Potential Glass and Silicone particulates in product
Recall initiated
January 19, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6

by Amneal Pharmaceuticals of New York, LLC

Reason
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Recall initiated
February 13, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1

by Apotex Corp.

Reason
CGMP Deviations: potential presence of Burkholderia cepacia complex
Recall initiated
February 9, 2024
Reported by FDA
February 28, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.

by IntegraDose Compounding Services LLC

Reason
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Recall initiated
January 22, 2024
Reported by FDA
February 21, 2024
Distribution
MN

View recall →

Drug Recall Terminated Historical recordClass II

HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Recall initiated
February 9, 2024
Reported by FDA
February 21, 2024
Distribution
The product was distributed nationwide within the United States.

View recall →

Drug Recall Ongoing Historical recordClass III

Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58

by Teva Pharmaceuticals USA, Inc

Reason
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Recall initiated
January 25, 2024
Reported by FDA
February 21, 2024
Distribution
nationwide

View recall →

Drug Recall Ongoing Historical recordClass III

Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67

by Teva Pharmaceuticals USA, Inc

Reason
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Recall initiated
January 25, 2024
Reported by FDA
February 21, 2024
Distribution
nationwide

View recall →

Drug Recall Ongoing Historical recordClass III

HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11

by Amerisource Health Services LLC

Reason
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Recall initiated
February 1, 2024
Reported by FDA
February 14, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01

by Amneal Pharmaceuticals of New York, LLC

Reason
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Recall initiated
January 15, 2024
Reported by FDA
February 14, 2024
Distribution
USA nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41

by NATCO Pharma Limited

Reason
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
Recall initiated
February 1, 2024
Reported by FDA
February 14, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44

by MEDLINE INDUSTRIES, LP - Northfield

Reason
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Recall initiated
January 10, 2024
Reported by FDA
February 14, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11

by Amerisource Health Services LLC

Reason
CGMP Deviations
Recall initiated
January 25, 2024
Reported by FDA
February 14, 2024
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass III

Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05

by Dr. Reddy's Laboratories, Inc.

Reason
Misprint on tablet
Recall initiated
January 18, 2024
Reported by FDA
February 14, 2024
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass III

Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01

by Dr. Reddy's Laboratories, Inc.

Reason
Misprint on tablet
Recall initiated
January 18, 2024
Reported by FDA
February 14, 2024
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30

by Kilitch Healthcare India Limited

Reason
Non-Sterility
Recall initiated
November 13, 2023
Reported by FDA
February 14, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass I

Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94

by Kilitch Healthcare India Limited

Reason
Non-Sterility
Recall initiated
November 13, 2023
Reported by FDA
February 14, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass I

Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid

by Kilitch Healthcare India Limited

Reason
Non-Sterility
Recall initiated
November 13, 2023
Reported by FDA
February 14, 2024
Distribution
Nationwide within the United States

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.