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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 5,421–5,440 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass III

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15

by Teligent Pharma, Inc.

Reason
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Recall initiated
February 2, 2021
Reported by FDA
May 5, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51

by Teligent Pharma, Inc.

Reason
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Recall initiated
February 2, 2021
Reported by FDA
May 5, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15

by Teligent Pharma, Inc.

Reason
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Recall initiated
February 2, 2021
Reported by FDA
May 5, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60

by Teligent Pharma, Inc.

Reason
Failed Impurities/Degradation Specifications:
Recall initiated
April 9, 2021
Reported by FDA
April 28, 2021
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Recall initiated
April 16, 2021
Reported by FDA
April 28, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8

by Noven Pharmaceuticals Inc

Reason
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Recall initiated
April 16, 2021
Reported by FDA
April 28, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178

by Edge Pharma, LLC

Reason
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Recall initiated
April 12, 2021
Reported by FDA
April 28, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass I

Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2911-90 (Pen) NDC 0169-2911-97 (Kit)

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-4060-99 (Kit)

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (Kit)

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2662-90

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Movo Mordisk Inc., Plainsboro, NJ 08536, NDC 0169-2660-90 (Pen), NDC 0169-2660-97 (Kit)

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2800-90 (Pen), NDC 0169-2800-97 (Kit)

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6339-90 (Pen), NDC 0169-6339-98 (Kit)

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6438-90 (Pen), NDC 0169-6438-98 (Kit)

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3201-90

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3205-91

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk, Inc., Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-3204-90 (Pen), NDC 0169-3204-97 (Kit)

by Novo Nordisk Inc

Reason
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Recall initiated
March 22, 2021
Reported by FDA
April 21, 2021
Distribution
Nationwide in the USA

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.