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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 9,581–9,600 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.

by AuroMedics Pharma LLC

Reason
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Recall initiated
May 1, 2018
Reported by FDA
May 16, 2018
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: no longer meets the specification for 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
May 4, 2018
Reported by FDA
May 16, 2018
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.

by Noven Pharmaceuticals, Inc.

Reason
Defective Delivery System: no longer meets the specification for 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
May 4, 2018
Reported by FDA
May 16, 2018
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass III

OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10

by Septodont Inc.

Reason
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
Recall initiated
April 13, 2018
Reported by FDA
May 16, 2018
Distribution
USA, Italy and France

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Drug Recall Terminated Historical recordClass II

Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL

by Coast Quality Pharmacy LLC

Reason
Lack of Assurance of Sterility
Recall initiated
April 26, 2018
Reported by FDA
May 16, 2018
Distribution
AL, CA, FL, MI, SC, TX

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Drug Recall Terminated Historical recordClass II

Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Imatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Sutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Sutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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Drug Recall Terminated Historical recordClass II

Dexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply

by Kroger Specialty Pharmacy, Inc.

Reason
Lack of Processing Controls.
Recall initiated
April 3, 2018
Reported by FDA
May 16, 2018
Distribution
MS, LA, AR, IL, FL

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.