Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 11,441–11,460 of 17,974 drug recalls

Drug Recall Completed Historical recordClass III

Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

by Par Pharmaceutical, Inc.

Reason
Subpotent Drug; Ethinyl Estradiol
Recall initiated
September 27, 2016
Reported by FDA
November 9, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass III

Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.

by Actavis Laboratories, FL, Inc.

Reason
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Recall initiated
August 30, 2016
Reported by FDA
November 9, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7

by Taro Pharmaceuticals, Inc.

Reason
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Recall initiated
September 13, 2016
Reported by FDA
November 9, 2016
Distribution
US & Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7

by Taro Pharmaceuticals, Inc.

Reason
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Recall initiated
September 13, 2016
Reported by FDA
November 9, 2016
Distribution
US & Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60

by Janssen Ortho L.L.C.

Reason
Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
Recall initiated
October 19, 2016
Reported by FDA
November 2, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25

by Boehringer Ingelheim Pharmaceuticals, Inc.

Reason
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Recall initiated
October 6, 2016
Reported by FDA
November 2, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01

by Boehringer Ingelheim Pharmaceuticals, Inc.

Reason
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Recall initiated
October 6, 2016
Reported by FDA
November 2, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15

by Supernus Pharmaceuticals, Inc.

Reason
Superpotent Drug: Failure of assay specifications in the capsule.
Recall initiated
July 12, 2016
Reported by FDA
October 26, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Recall initiated
September 22, 2016
Reported by FDA
October 26, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Recall initiated
September 22, 2016
Reported by FDA
October 26, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Recall initiated
September 22, 2016
Reported by FDA
October 26, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Dream Body Advanced 400 mg 30 capsules in brown foil packets.

by Dream Body Weight Loss

Reason
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Recall initiated
July 1, 2016
Reported by FDA
October 26, 2016
Distribution
United States

View recall →

Drug Recall Terminated Historical recordClass II

Dream Body 450 mg 30 capsules in a plastic screw on top bottle

by Dream Body Weight Loss

Reason
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Recall initiated
July 1, 2016
Reported by FDA
October 26, 2016
Distribution
United States

View recall →

Drug Recall Terminated Historical recordClass II

Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle

by Dream Body Weight Loss

Reason
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Recall initiated
July 1, 2016
Reported by FDA
October 26, 2016
Distribution
United States

View recall →

Drug Recall Terminated Historical recordClass I

Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister packs), Distributed by Arbor Pharmaceuticals, LLC Atlanta, GA 30328, NDC 24338-700-10.

by Arbor Pharmaceuticals Inc.

Reason
Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.
Recall initiated
July 21, 2016
Reported by FDA
October 26, 2016
Distribution
CA, FL, GA, LA, MO, MS, NC, OH, PA, SC, TN, TX, VA and WV.

View recall →

Drug Recall Terminated Historical recordClass I

Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.

by SOS Telecom Inc.

Reason
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Recall initiated
May 12, 2016
Reported by FDA
October 26, 2016
Distribution
NY

View recall →

Drug Recall Terminated Historical recordClass I

Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box.

by SOS Telecom Inc.

Reason
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Recall initiated
May 12, 2016
Reported by FDA
October 26, 2016
Distribution
NY

View recall →

Drug Recall Terminated Historical recordClass I

Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box.

by SOS Telecom Inc.

Reason
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Recall initiated
May 12, 2016
Reported by FDA
October 26, 2016
Distribution
NY

View recall →

Drug Recall Terminated Historical recordClass I

Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box

by SOS Telecom Inc.

Reason
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Recall initiated
May 12, 2016
Reported by FDA
October 26, 2016
Distribution
NY

View recall →

Drug Recall Terminated Historical recordClass II

morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3181.

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 →

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.