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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 5,761–5,780 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 10 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-278-10

by ANI Pharmaceuticals, Inc.

Reason
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Recall initiated
October 9, 2020
Reported by FDA
October 28, 2020
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 5 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-277-10

by ANI Pharmaceuticals, Inc.

Reason
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Recall initiated
October 9, 2020
Reported by FDA
October 28, 2020
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai, 200245, China for Sandoz Inc. Princeton, NJ 08540, NDC 0781-6172-22

by eVenus Pharmaceutical Laboratories

Reason
DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
Recall initiated
October 6, 2020
Reported by FDA
October 28, 2020
Distribution
CO only

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Drug Recall Ongoing Historical recordClass II

Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC 20009, NDC 74625-003-05, UPC 7401037203427.

by Genesis Partnership Company SA

Reason
Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Recall initiated
September 11, 2020
Reported by FDA
October 28, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Killz Germz, LLC., 1912 R street NW, Washington DC, 20009, NDC 74625-003-04, UPC 7401037203250.

by Genesis Partnership Company SA

Reason
Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Recall initiated
September 11, 2020
Reported by FDA
October 28, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427.

by Genesis Partnership Company SA

Reason
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Recall initiated
September 11, 2020
Reported by FDA
October 28, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773.

by Genesis Partnership Company SA

Reason
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Recall initiated
September 11, 2020
Reported by FDA
October 28, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.

by Genesis Partnership Company SA

Reason
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Recall initiated
September 11, 2020
Reported by FDA
October 28, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass I

NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01

by Acella Pharmaceuticals, LLC

Reason
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Recall initiated
September 17, 2020
Reported by FDA
October 28, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass I

NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01

by Acella Pharmaceuticals, LLC

Reason
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Recall initiated
September 17, 2020
Reported by FDA
October 28, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass I

Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #: 92317-144, UPC 8 50016 92317 2, NDC 70108-045-01); d) Barbie (Item #: 92318-144, UPC 8 50016 92318 9, NDC 70108-046-01); e) Trolls (Item #: 92322-144, UPC 8 50016 92322 6, NDC 70108-047-01); and f) Minions (Item #: 92319-144, UPC 8 50016 92319 6, NDC 70108-043-01); Distributed by Ashtel Studios Inc., Ontario, CA 91761

by ASHTEL STUDIOS, INC.

Reason
Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
Recall initiated
October 1, 2020
Reported by FDA
October 21, 2020
Distribution
Pouches of .84 oz.hand sanitizer were distributed to the following states: CA, IL, and Ontario Canada

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Drug Recall Terminated Historical recordClass III

Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01

by Leadiant Biosciences, Inc.

Reason
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Recall initiated
September 24, 2020
Reported by FDA
October 21, 2020
Distribution
PA and Italy

View recall →

Drug Recall Terminated Historical recordClass III

NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,

by VistaPharm, Inc.

Reason
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Recall initiated
September 25, 2020
Reported by FDA
October 14, 2020
Distribution
Distributed Nationwide in the USA including Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30

by Direct Rx

Reason
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Recall initiated
April 30, 2019
Reported by FDA
October 14, 2020
Distribution
GA

View recall →

Drug Recall Terminated Historical recordClass II

Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30

by Direct Rx

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
January 15, 2020
Reported by FDA
October 14, 2020
Distribution
FL, GA

View recall →

Drug Recall Terminated Historical recordClass II

Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534

by Direct Rx

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
January 15, 2020
Reported by FDA
October 14, 2020
Distribution
FL, GA

View recall →

Drug Recall Terminated Historical recordClass III

Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40

by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Reason
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
Recall initiated
September 9, 2020
Reported by FDA
October 14, 2020
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10

by Calvin Scott & Company, Inc.

Reason
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Recall initiated
September 16, 2020
Reported by FDA
October 14, 2020
Distribution
Repacked drug products distributed to 12 physician consignees located in the following states: CA, ID, IL,OK, RI

View recall →

Drug Recall Terminated Historical recordClass II

Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01

by Calvin Scott & Company, Inc.

Reason
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Recall initiated
September 16, 2020
Reported by FDA
October 14, 2020
Distribution
Repacked drug products distributed to 12 physician consignees located in the following states: CA, ID, IL,OK, RI

View recall →

Drug Recall Terminated Historical recordClass II

Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01

by Calvin Scott & Company, Inc.

Reason
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
Recall initiated
September 16, 2020
Reported by FDA
October 14, 2020
Distribution
Repacked drug products distributed to 12 physician consignees located in the following states: CA, ID, IL,OK, RI

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.