Skip to main content

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 5,001–5,020 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass I

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1

by Global Sanitizers LLC

Reason
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Recall initiated
May 12, 2021
Reported by FDA
September 8, 2021
Distribution
Product Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00420 8,

by Global Sanitizers LLC

Reason
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Recall initiated
May 12, 2021
Reported by FDA
September 8, 2021
Distribution
Product Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC 6 76753 00414 7

by Global Sanitizers LLC

Reason
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Recall initiated
May 12, 2021
Reported by FDA
September 8, 2021
Distribution
Product Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00417 8

by Global Sanitizers LLC

Reason
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Recall initiated
May 12, 2021
Reported by FDA
September 8, 2021
Distribution
Product Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36

by Granules USA, Inc.

Reason
CGMP Deviations
Recall initiated
August 11, 2021
Reported by FDA
September 8, 2021
Distribution
NY

View recall →

Drug Recall Terminated Historical recordClass II

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Recall initiated
July 29, 2021
Reported by FDA
September 8, 2021
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Recall initiated
July 29, 2021
Reported by FDA
September 8, 2021
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
Recall initiated
July 29, 2021
Reported by FDA
September 8, 2021
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80

by Eli Lilly & Company

Reason
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Recall initiated
August 19, 2021
Reported by FDA
September 1, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21.

by KVK-Tech, Inc.

Reason
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Recall initiated
July 2, 2021
Reported by FDA
September 1, 2021
Distribution
Product was distributed to one distributor who may have further distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass III

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01

by Hikma Pharmaceuticals USA Inc.

Reason
Labeling: Not elsewhere classified: Mislabeling
Recall initiated
August 5, 2021
Reported by FDA
September 1, 2021
Distribution
USA nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030

by HIS ENTERPRISE INC

Reason
Marketed without ANDA/NDA approval
Recall initiated
July 20, 2021
Reported by FDA
September 1, 2021
Distribution
USA nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59

by Teligent Pharma, Inc.

Reason
Defective container: possibility for lack of seal integrity.
Recall initiated
July 29, 2021
Reported by FDA
September 1, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903

by SterRx, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
August 10, 2021
Reported by FDA
September 1, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass I

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01

by SterRx, LLC

Reason
Non-Sterility: firm's third party lab confirmed microbial contamination.
Recall initiated
August 10, 2021
Reported by FDA
September 1, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4

by SigmaPharm Laboratories LLC

Reason
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Recall initiated
August 13, 2021
Reported by FDA
September 1, 2021
Distribution
Disttibuted Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01

by Custopharm, Inc.

Reason
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Recall initiated
July 30, 2021
Reported by FDA
September 1, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Recall initiated
July 23, 2021
Reported by FDA
September 1, 2021
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208.

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Recall initiated
July 23, 2021
Reported by FDA
September 1, 2021
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192.

by Professional Disposables International, Inc

Reason
SubPotent: Out of Specification
Recall initiated
July 23, 2021
Reported by FDA
September 1, 2021
Distribution
Distributed Nationwide in the US

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.