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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 5,161–5,180 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass III

DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) 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 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50

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 →

Drug Recall Terminated Historical recordClass II

Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10

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 I

1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.

by PFIZER, INC

Reason
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Recall initiated
May 3, 2021
Reported by FDA
June 9, 2021
Distribution
Nationwide in the USA, Puerto Rico, and Guam

View recall →

Drug Recall Terminated Historical recordClass I

0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.

by PFIZER, INC

Reason
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Recall initiated
May 3, 2021
Reported by FDA
June 9, 2021
Distribution
Nationwide in the USA, Puerto Rico, and Guam

View recall →

Drug Recall Completed Historical recordClass II

BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10

by Oxford Pharmaceuticals, LLC

Reason
Presence of Foreign Tablets/Capsules
Recall initiated
May 5, 2021
Reported by FDA
June 9, 2021
Distribution
USA Nationwide.

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Drug Recall Terminated Historical recordClass III

Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02

by Mylan Institutional LLC

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
Recall initiated
May 3, 2021
Reported by FDA
June 9, 2021
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877

by Boehringer Ingelheim Pharmaceuticals, Inc.

Reason
Subpotent Drug
Recall initiated
May 4, 2021
Reported by FDA
June 9, 2021
Distribution
AR, CO, CT, LA, NC, ND, NH, NJ, OH, PA and PR

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Drug Recall Terminated Historical recordClass II

Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111 NDC: 69423-903-41, UPC 0 37000 28803 9

by Accupac, Inc.

Reason
Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Recall initiated
May 13, 2021
Reported by FDA
June 2, 2021
Distribution
Naitonwide in the US and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules Rx Only NDC 13811-539-90 Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 tablets each, Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-9034-58

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5985-27

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5986-27

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-579-22 Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

View recall →

Drug Recall Terminated Historical recordClass II

COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683

by Cardinal Health Inc.

Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall initiated
March 15, 2021
Reported by FDA
June 2, 2021
Distribution
FL, GA, SC

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.