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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 10,301–10,320 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn, NY 11232. UPC 5842109854239

by Shata Trading, Inc.

Reason
Marketed Without an Approved NDA/ANDA
Recall initiated
August 22, 2017
Reported by FDA
November 29, 2017
Distribution
NY

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Drug Recall Terminated Historical recordClass II

TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, Rx Only, Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709, NDC# 6630220601

by United Therapeutics Corp.

Reason
CGMP Deviations
Recall initiated
September 11, 2017
Reported by FDA
November 29, 2017
Distribution
PA

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Drug Recall Terminated Historical recordClass III

Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06

by Jubilant Cadista Pharmaceuticals, Inc.

Reason
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Recall initiated
October 30, 2017
Reported by FDA
November 22, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, Rx Only, 100-count bottle, Manufactured For: Llorens Pharmaceutical Corp., International Division, Miami, FL 33166. NDC: 54859-701-10

by Llorens Pharmaceutical Corp.

Reason
Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.
Recall initiated
September 5, 2017
Reported by FDA
November 22, 2017
Distribution
Puerto Rico

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Drug Recall Terminated Historical recordClass II

Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40

by PharMEDium Services, LLC.

Reason
Superpotent drug: out of specification result for potency
Recall initiated
October 13, 2017
Reported by FDA
November 22, 2017
Distribution
CA, IL

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Drug Recall Terminated Historical recordClass II

Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967

by Fagron, Inc

Reason
cGMP Deviations: lack of quality assurance at the API manufacturer.
Recall initiated
October 25, 2017
Reported by FDA
November 22, 2017
Distribution
Nationwide in USA

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Drug Recall Terminated Historical recordClass III

Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03

by Allergan Sales, LLC

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
October 19, 2017
Reported by FDA
November 22, 2017
Distribution
Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.

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Drug Recall Terminated Historical recordClass III

Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..

by Allergan Sales, LLC

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
October 19, 2017
Reported by FDA
November 22, 2017
Distribution
Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.

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Drug Recall Terminated Historical recordClass II

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7

by Amneal Pharmaceuticals LLC

Reason
Presence of Particulate Matter
Recall initiated
August 31, 2017
Reported by FDA
November 22, 2017
Distribution
MS, NC, OH, TX, UT

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Drug Recall Terminated Historical recordClass III

Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.

by Genzyme Corporation

Reason
Labeling: Incorrect or Missing Package Insert.
Recall initiated
October 12, 2017
Reported by FDA
November 22, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01

by Amerisource Health Services

Reason
Failed Stability Specifications
Recall initiated
August 29, 2017
Reported by FDA
November 22, 2017
Distribution
Nationwide USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023

by Dr. Reddy's Laboratories, Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
Recall initiated
October 30, 2017
Reported by FDA
November 15, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Succinylcholine 20 MG/ML INJ (QUELICIN), 10 ML Vials, Rx only, Distributed by: ACE Surgical Co., Inc., Brockton, MA

by Ace Surgical Supply Co., Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
Recall initiated
October 24, 2017
Reported by FDA
November 15, 2017
Distribution
Product was distributed throughout the United States.

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Drug Recall Terminated Historical recordClass II

Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01

by Purdue Pharma, LP

Reason
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
Recall initiated
October 5, 2017
Reported by FDA
November 15, 2017
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.

by Teva Pharmaceuticals USA

Reason
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Recall initiated
October 25, 2017
Reported by FDA
November 8, 2017
Distribution
Nationwide in the USA and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09

by SCA Pharmaceuticals, LLC

Reason
Lack Of Assurance Of Sterility.
Recall initiated
October 19, 2017
Reported by FDA
November 8, 2017
Distribution
Nationwide in the United States

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Drug Recall Terminated Historical recordClass II

Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30

by SCA Pharmaceuticals, LLC

Reason
Lack Of Assurance Of Sterility.
Recall initiated
October 19, 2017
Reported by FDA
November 8, 2017
Distribution
Nationwide in the United States

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Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12

by SCA Pharmaceuticals, LLC

Reason
Lack Of Assurance Of Sterility.
Recall initiated
October 19, 2017
Reported by FDA
November 8, 2017
Distribution
Nationwide in the United States

View recall →

Drug Recall Terminated Historical recordClass II

oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44

by SCA Pharmaceuticals, LLC

Reason
Lack Of Assurance Of Sterility.
Recall initiated
October 19, 2017
Reported by FDA
November 8, 2017
Distribution
Nationwide in the United States

View recall →

Drug Recall Terminated Historical recordClass II

morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205

by SCA Pharmaceuticals, LLC

Reason
Lack Of Assurance Of Sterility.
Recall initiated
October 19, 2017
Reported by FDA
November 8, 2017
Distribution
Nationwide in the United States

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.