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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 10,261–10,280 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India

by Renaissance Lakewood, LLC

Reason
Superpotent
Recall initiated
November 11, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02

by Pfizer Inc.

Reason
Presence of Particulate Matter: glass particulate found in vial
Recall initiated
August 30, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.

by EZWeightLossTX LLC

Reason
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Recall initiated
July 24, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.

by EZWeightLossTX LLC

Reason
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Recall initiated
July 24, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84

by Amneal Pharmaceuticals of New York, LLC

Reason
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Recall initiated
August 3, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.

by Advanced Pharma Inc.

Reason
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Recall initiated
June 9, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide in the USA to hospitals and medical facilities.

View recall →

Drug Recall Terminated Historical recordClass II

NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.

by Advanced Pharma Inc.

Reason
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Recall initiated
June 9, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide in the USA to hospitals and medical facilities.

View recall →

Drug Recall Terminated Historical recordClass II

NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.

by Advanced Pharma Inc.

Reason
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Recall initiated
June 9, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide in the USA to hospitals and medical facilities.

View recall →

Drug Recall Terminated Historical recordClass II

NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.

by Advanced Pharma Inc.

Reason
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Recall initiated
June 9, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide in the USA to hospitals and medical facilities.

View recall →

Drug Recall Terminated Historical recordClass I

NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.

by Advanced Pharma Inc.

Reason
Subpotent Drug: found to be below the specification for labeled assay.
Recall initiated
June 9, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide in the USA to hospitals and medical facilities.

View recall →

Drug Recall Terminated Historical recordClass I

NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.

by Advanced Pharma Inc.

Reason
Subpotent Drug: found to be below the specification for labeled assay.
Recall initiated
June 9, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide in the USA to hospitals and medical facilities.

View recall →

Drug Recall Terminated Historical recordClass I

NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.

by Advanced Pharma Inc.

Reason
Subpotent Drug: found to be below the specification for labeled assay.
Recall initiated
June 9, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide in the USA to hospitals and medical facilities.

View recall →

Drug Recall Terminated Historical recordClass II

0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10

by B. Braun Medical Inc

Reason
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Recall initiated
December 15, 2017
Reported by FDA
December 27, 2017
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10

by Osmotica Pharmaceutical Corp

Reason
Subpotent Drug
Recall initiated
December 18, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10

by Osmotica Pharmaceutical Corp

Reason
Subpotent Drug
Recall initiated
December 18, 2017
Reported by FDA
December 27, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512

by Sun Pharmaceutical Industries, Inc.

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
April 18, 2017
Reported by FDA
December 20, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Recall initiated
November 28, 2017
Reported by FDA
December 20, 2017
Distribution
Nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass III

Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013

by Elite Laboratories Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
November 13, 2017
Reported by FDA
December 13, 2017
Distribution
NY only

View recall →

Drug Recall Terminated Historical recordClass I

grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distributed by Grande X Ontario, CA 91745, UPC 640793555440

by Gadget Island, Inc

Reason
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Recall initiated
September 15, 2017
Reported by FDA
December 13, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056

by Gadget Island, Inc

Reason
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Recall initiated
September 15, 2017
Reported by FDA
December 13, 2017
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.