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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 5,601–5,620 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68

by Ascend Laboratories LLC

Reason
Failed Impurity/Degradation Specifications
Recall initiated
December 17, 2020
Reported by FDA
January 6, 2021
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88

by Ascend Laboratories LLC

Reason
Failed Impurity/Degradation Specifications
Recall initiated
December 17, 2020
Reported by FDA
January 6, 2021
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979

by Imprimis NJOF, LLC

Reason
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Recall initiated
December 17, 2020
Reported by FDA
January 6, 2021
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass III

Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05

by US Compounding Inc

Reason
Labelling: Missing label.
Recall initiated
November 25, 2020
Reported by FDA
January 6, 2021
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

by Morton Grove Pharmaceuticals, Inc.

Reason
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Recall initiated
December 9, 2020
Reported by FDA
December 30, 2020
Distribution
Nationwide USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

by Fresenius Kabi USA, LLC

Reason
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Recall initiated
December 10, 2020
Reported by FDA
December 30, 2020
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232

by SCA Pharmaceuticals, Inc.

Reason
Subpotent drug.
Recall initiated
December 14, 2020
Reported by FDA
December 30, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01

by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Reason
CGMP Deviations
Recall initiated
December 9, 2020
Reported by FDA
December 30, 2020
Distribution
The product was distributed by two major distributors who further distributed the product nationwide and one specialty pharmacy.

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17

by Hikma Pharmaceuticals USA Inc.

Reason
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Recall initiated
December 7, 2020
Reported by FDA
December 23, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10

by AVKARE Inc.

Reason
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Recall initiated
December 7, 2020
Reported by FDA
December 23, 2020
Distribution
Nationwide within the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.

by AVKARE Inc.

Reason
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Recall initiated
December 7, 2020
Reported by FDA
December 23, 2020
Distribution
Nationwide within the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40

by CIPLA

Reason
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Recall initiated
December 14, 2020
Reported by FDA
December 23, 2020
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Lavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC. 1130 Aba St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico, Barcode: 7 05333 5897

by Simex Logistics SA de CV

Reason
Subpotent drug
Recall initiated
November 25, 2020
Reported by FDA
December 23, 2020
Distribution
CA, GA, NV, TX

View recall →

Drug Recall Terminated Historical recordClass II

UVT World Gel Hand Sanitizer 70% Alcohol Content, 33.9 FL OZ (1LT), Distributed By UVT World Newport Beach, CA 92660 www.uvt.world Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente Celaya, Guanajuato, Mexico Barcode: 7 00306 88677 2

by Simex Logistics SA de CV

Reason
Subpotent drug
Recall initiated
November 25, 2020
Reported by FDA
December 23, 2020
Distribution
CA, GA, NV, TX

View recall →

Drug Recall Terminated Historical recordClass II

Health & Hand Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed By Blue Ridge Southern Supply, LLC 1130 Ada St. Blue Ridge, GA 30513 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fracc. El Puente C.P. 38040 Celaya, Guanajuato, Mexico. smxcontact@simex-logistics.com Barcode: 6 18149 21988 9

by Simex Logistics SA de CV

Reason
Subpotent drug
Recall initiated
November 25, 2020
Reported by FDA
December 23, 2020
Distribution
CA, GA, NV, TX

View recall →

Drug Recall Terminated Historical recordClass II

CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81 FL OZ (1L), Distributed By Citru Gel Inc. Henderson, NV 89052 www.citrugel.com NDC: 78247-002-01

by Simex Logistics SA de CV

Reason
Subpotent drug
Recall initiated
November 25, 2020
Reported by FDA
December 23, 2020
Distribution
CA, GA, NV, TX

View recall →

Drug Recall Terminated Historical recordClass II

+Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic, packaged in bottles of a) 33.8 Oz (1000mL) Barcode: GOOD-GEL-04062020L; b) 127.8 oz (3780mL) Barcode 0723707893163, Distributed by: PS Promotional Services LLC Allen Street #406 Dallas, Texas 75204 Produced By: Simex Logistics S.A. de C.V. Salvatierra No. 101 Fraccionamiento El Puente. Celaya, Guanajuato, Mexico.

by Simex Logistics SA de CV

Reason
Subpotent drug
Recall initiated
November 25, 2020
Reported by FDA
December 23, 2020
Distribution
CA, GA, NV, TX

View recall →

Drug Recall Terminated Historical recordClass II

Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz (30 g), Distributed by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10531. Made in Canada. UPC 3 51672 20022 0

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Recall initiated
November 17, 2020
Reported by FDA
December 23, 2020
Distribution
Distributed Nationwide in the USA and Canada

View recall →

Drug Recall Terminated Historical recordClass II

TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 49569 2

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Recall initiated
November 17, 2020
Reported by FDA
December 23, 2020
Distribution
Distributed Nationwide in the USA and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), Distributed by: Valu Merchandisers, CO . 5000 Kansas Ave. Kansas City, KS 66106 Made in Canada. UPC 0-70038-20355-1

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Recall initiated
November 17, 2020
Reported by FDA
December 23, 2020
Distribution
Distributed Nationwide in the USA and Canada

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.