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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 5,341–5,360 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS)

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 60631-425-30 Manufactured for Arbor Pharmaceuticals Atlanta, GA 30328

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution) Rx Only NDC 47781-384-26 Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 35242

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

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.