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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 8,781–8,800 of 17,964 drug recalls

Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recall initiated
December 31, 2018
Reported by FDA
January 23, 2019
Distribution
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.

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Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recall initiated
December 31, 2018
Reported by FDA
January 23, 2019
Distribution
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.

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Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recall initiated
December 31, 2018
Reported by FDA
January 23, 2019
Distribution
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.

View recall →

Drug Recall Ongoing Historical recordClass II

Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Recall initiated
December 31, 2018
Reported by FDA
January 23, 2019
Distribution
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.

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Drug Recall Completed Historical recordClass II

OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07

by Allergan, PLC.

Reason
GMP Deviations: A silicone particulate was noted in Ozurdex.
Recall initiated
December 20, 2018
Reported by FDA
January 16, 2019
Distribution
Product was distributed to various accounts throughout the United States including VA and Government Accounts

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Drug Recall Terminated Historical recordClass II

Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Recall initiated
January 2, 2019
Reported by FDA
January 16, 2019
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Recall initiated
January 2, 2019
Reported by FDA
January 16, 2019
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.

by PharMEDium Services, LLC.

Reason
Subpotent
Recall initiated
January 2, 2019
Reported by FDA
January 16, 2019
Distribution
Product was distributed throughout the United States.

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Drug Recall Terminated Historical recordClass I

Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC: 47335-932-40 [vial] 47335-932-44 [carton]

by Sun Pharmaceutical Industries, Inc.

Reason
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Recall initiated
January 3, 2019
Reported by FDA
January 16, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton]

by Sun Pharmaceutical Industries, Inc.

Reason
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Recall initiated
January 3, 2019
Reported by FDA
January 16, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.

by Lupin Pharmaceuticals Inc.

Reason
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Recall initiated
December 20, 2018
Reported by FDA
January 16, 2019
Distribution
Nationwide in the USA and Puerto Rico.

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Drug Recall Terminated Historical recordClass I

Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

by Lupin Pharmaceuticals Inc.

Reason
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Recall initiated
December 20, 2018
Reported by FDA
January 16, 2019
Distribution
Nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass I

Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

by Lupin Pharmaceuticals Inc.

Reason
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Recall initiated
December 20, 2018
Reported by FDA
January 16, 2019
Distribution
Nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass I

Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

by Lupin Pharmaceuticals Inc.

Reason
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Recall initiated
December 20, 2018
Reported by FDA
January 16, 2019
Distribution
Nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31

by Heritage Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Recall initiated
January 2, 2019
Reported by FDA
January 16, 2019
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.

by Baxter Healthcare Corporation

Reason
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Recall initiated
January 2, 2019
Reported by FDA
January 16, 2019
Distribution
Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.

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Drug Recall Terminated Historical recordClass II

Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ

by Glenmark Pharmaceuticals Inc., USA

Reason
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Recall initiated
December 26, 2018
Reported by FDA
January 16, 2019
Distribution
Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.

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Drug Recall Terminated Historical recordClass II

Lidocaine gel 1%, RX, plastic dropper

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

Glutathione liquid, 200mg/ml, Rx

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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Drug Recall Terminated Historical recordClass II

Cyclosporin liquid 0.05%, Rx, plastic dropper bottle

by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Reason
Lack of sterility assurance.
Recall initiated
January 2, 2019
Reported by FDA
January 9, 2019
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.

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.