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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 5,481–5,500 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass III

Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-2; b) Professional Sample Kit: 3 single dose vials of Menotropins for injection, 3 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-3; Rx Only, Manufactured for Ferring Pharmaceuticals Inc. Parsippany. NJ 07054. Diluent manufactured for Ferring Pharmaceuticals Inc.

by Ferring Pharmaceuticals Inc

Reason
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Recall initiated
March 2, 2021
Reported by FDA
March 17, 2021
Distribution
Distributed nationwide in the USA.

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Drug Recall Terminated Historical recordClass III

Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Recall initiated
February 19, 2021
Reported by FDA
March 10, 2021
Distribution
USA nationwide, including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray)

by Teva Pharmaceuticals USA

Reason
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Recall initiated
February 15, 2021
Reported by FDA
March 10, 2021
Distribution
Nationwide, including Puerto Rico

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Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5555-3.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for mechanical peel.
Recall initiated
February 19, 2021
Reported by FDA
March 10, 2021
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5554-3.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for mechanical peel.
Recall initiated
February 19, 2021
Reported by FDA
March 10, 2021
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5553-3.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for mechanical peel.
Recall initiated
February 19, 2021
Reported by FDA
March 10, 2021
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3.

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for mechanical peel.
Recall initiated
February 19, 2021
Reported by FDA
March 10, 2021
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Recall initiated
February 26, 2021
Reported by FDA
March 10, 2021
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Recall initiated
February 19, 2021
Reported by FDA
March 10, 2021
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99

by Aurobindo Pharma USA Inc.

Reason
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Recall initiated
January 20, 2021
Reported by FDA
March 10, 2021
Distribution
TX, CA, GA, PA

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Drug Recall Terminated Historical recordClass III

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Subpotent
Recall initiated
February 22, 2021
Reported by FDA
March 10, 2021
Distribution
Nationwide and Australia

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Drug Recall Terminated Historical recordClass I

Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06), Rx only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL 60631.

by Meitheal Pharmaceuticals Inc

Reason
Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
Recall initiated
January 27, 2021
Reported by FDA
March 3, 2021
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0063-01.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0043-01.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-0045-01.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-5140-01.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva Pharmaceuticals, Inc., Gerogetown, IN 47122, Made in India, NDC 59923-714-02.

by Areva Pharmaceuticals Inc

Reason
CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
Recall initiated
November 19, 2020
Reported by FDA
March 3, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distributed by Ndal Laboratories, 449 Alvarado St., Monterey, CA 93940 (bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8. the Alvarado St. is for the bottle by putting "(bottle); NDAL MFG Inc., 80 Garden Court, Suite 100, Monterey, CA 93940 (carton); UPC 8 58631 00212 8." (according to the label)

by NDAL Mfg Inc.

Reason
Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Recall initiated
December 17, 2020
Reported by FDA
March 3, 2021
Distribution
Distributed Nationwide in the USA and Hong Kong

View recall →

Drug Recall Terminated Historical recordClass I

ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400

by CareFusion 213, LLC

Reason
Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Recall initiated
July 7, 2020
Reported by FDA
March 3, 2021
Distribution
Distributed in Puerto Rico and Oman

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.