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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 5,141–5,160 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01

by VIONA PHARMACEUTICALS INC

Reason
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Recall initiated
June 1, 2021
Reported by FDA
June 30, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass III

Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30

by Bausch Health Companies, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
June 8, 2021
Reported by FDA
June 30, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.

by Bausch Health Companies, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
June 8, 2021
Reported by FDA
June 30, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20

by Hill Dermaceuticals, Inc.

Reason
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Recall initiated
May 21, 2021
Reported by FDA
June 30, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.

by Teligent Pharma, Inc.

Reason
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Recall initiated
May 14, 2021
Reported by FDA
June 30, 2021
Distribution
Nationwide in the United States

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Drug Recall Terminated Historical recordClass I

maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028

by Miracle 8989

Reason
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Recall initiated
May 18, 2021
Reported by FDA
June 30, 2021
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass I

PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006

by Miracle 8989

Reason
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Recall initiated
May 18, 2021
Reported by FDA
June 30, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006

by Miracle 8989

Reason
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Recall initiated
May 18, 2021
Reported by FDA
June 30, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite 2 Simpsonville, SC 29681. NDC: 73463-0100-01

by Prisma Health Outsourcing Facility

Reason
Labeling: Incorrect Exp. Date: Incorrect BUD.
Recall initiated
June 8, 2021
Reported by FDA
June 23, 2021
Distribution
Distributed in South Carolina

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Drug Recall Terminated Historical recordClass II

QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou

by World Source Llc

Reason
Subpotent
Recall initiated
June 9, 2021
Reported by FDA
June 23, 2021
Distribution
Product was distributed to two hospitals in NY.

View recall →

Drug Recall Terminated Historical recordClass III

Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13

by AVKARE Inc.

Reason
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Recall initiated
June 9, 2021
Reported by FDA
June 23, 2021
Distribution
Distributed in Los Angeles California

View recall →

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Recall initiated
June 4, 2021
Reported by FDA
June 23, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg

by DASH XCLUSIVE

Reason
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Recall initiated
May 11, 2021
Reported by FDA
June 23, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Distributed By: McKesson Corporation 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India NDC 63739-795-10

by McKesson Corporation dba McKesson Drug Company

Reason
Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
Recall initiated
May 26, 2021
Reported by FDA
June 16, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass III

READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-244-01

by Medline Industries Inc

Reason
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Recall initiated
May 14, 2021
Reported by FDA
June 16, 2021
Distribution
Distributed Nationwide in the USA and Isreal

View recall →

Drug Recall Terminated Historical recordClass III

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451

by Fresenius Medical Care Holdings, Inc.

Reason
Temperature Abuse: Product exposed to temperature outside specified limits.
Recall initiated
April 28, 2021
Reported by FDA
June 16, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92

by Fresenius Medical Care Holdings, Inc.

Reason
Temperature Abuse: Product exposed to temperature outside specified limits.
Recall initiated
April 28, 2021
Reported by FDA
June 16, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,

by Fresenius Medical Care Holdings, Inc.

Reason
Temperature Abuse: Product exposed to temperature outside specified limits.
Recall initiated
April 28, 2021
Reported by FDA
June 16, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92

by Fresenius Medical Care Holdings, Inc.

Reason
Temperature Abuse: Product exposed to temperature outside specified limits.
Recall initiated
April 28, 2021
Reported by FDA
June 16, 2021
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50

by Fresenius Medical Care Holdings, Inc.

Reason
Temperature Abuse: Product exposed to temperature outside specified limits.
Recall initiated
April 28, 2021
Reported by FDA
June 16, 2021
Distribution
Nationwide within the United States

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.