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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 11,521–11,540 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3329.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a 3 mL BD Syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6107.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.

by PharMEDium Services, LLC

Reason
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3308.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3301.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335.

by PharMEDium Services, LLC

Reason
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Recall initiated
July 17, 2015
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).

by Teva Pharmaceuticals USA

Reason
CGMP Deviations
Recall initiated
July 29, 2016
Reported by FDA
October 19, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85

by The Harvard Drug Group

Reason
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Recall initiated
July 15, 2016
Reported by FDA
October 19, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA

by Bee Xtreme

Reason
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Recall initiated
December 23, 2015
Reported by FDA
October 19, 2016
Distribution
Unknown

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.