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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 1,581–1,600 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722-246-04; Little Moon Essentials LLC Dania Beach, Fl 33004

by Little Moon Essentials LLC

Reason
CGMP deviations
Recall initiated
June 20, 2024
Reported by FDA
July 10, 2024
Distribution
Nationwide USA and Ontario, Canada (2 retailers)

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Drug Recall Completed Historical recordClass II

Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

by Medisca Inc.

Reason
CGMP Deviations and Presence of Particulate Matter: Glass
Recall initiated
June 26, 2024
Reported by FDA
July 10, 2024
Distribution
Nationwide in the USA and Canada

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Drug Recall Ongoing Historical recordClass III

SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.

by Neilmed Pharmaceuticals Inc

Reason
Sub-potent Drug
Recall initiated
June 24, 2024
Reported by FDA
July 3, 2024
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.

by Golden State Medical Supply Inc.

Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Recall initiated
May 13, 2024
Reported by FDA
July 3, 2024
Distribution
Nationwide in the U.S.

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Drug Recall Ongoing Historical recordClass II

Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01

by PACIRA PHARMACEUTICALS INC

Reason
Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Recall initiated
June 12, 2024
Reported by FDA
July 3, 2024
Distribution
US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606

by Contract Pharmacal Corporation

Reason
Discoloration: Brownish tablets
Recall initiated
May 20, 2024
Reported by FDA
July 3, 2024
Distribution
MI

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Drug Recall Ongoing Historical recordClass II

Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24

by Pfizer Inc.

Reason
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Recall initiated
May 20, 2024
Reported by FDA
July 3, 2024
Distribution
US Nationwide and Puerto Rico.

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Drug Recall Ongoing Historical recordClass II

Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2012-03

by Pfizer Inc.

Reason
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Recall initiated
May 20, 2024
Reported by FDA
July 3, 2024
Distribution
US Nationwide and Puerto Rico.

View recall →

Drug Recall Completed Historical recordClass II

Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, 5710 Hoover Blvd, Tampa, Fl 33643, (800)-995-4363. Beyond Use Date: 09/08/2024.

by Coast Quality Pharmacy, LLC dba Anazao Health

Reason
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Recall initiated
April 24, 2024
Reported by FDA
July 3, 2024
Distribution
U.S. Nationwide

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Drug Recall Terminated Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated
May 17, 2024
Reported by FDA
June 26, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34

by Teva Pharmaceuticals USA, Inc

Reason
Subpotent Drug
Recall initiated
June 4, 2024
Reported by FDA
June 26, 2024
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-75051-8; CVS, with UPC 0-50428-31702-0

by Consumer Product Partners, LLC

Reason
Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Recall initiated
May 28, 2024
Reported by FDA
June 26, 2024
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03

by Lupin Pharmaceuticals Inc.

Reason
Failed Content Uniformity Specifications
Recall initiated
May 30, 2024
Reported by FDA
June 26, 2024
Distribution
Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370

by MexHealth LLC

Reason
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Recall initiated
May 22, 2024
Reported by FDA
June 26, 2024
Distribution
US Nationwide

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Drug Recall Terminated Historical recordClass II

Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02

by Denison Pharmaceuticals, LLC

Reason
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Recall initiated
May 28, 2024
Reported by FDA
June 26, 2024
Distribution
Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.

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Drug Recall Ongoing Historical recordClass III

Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10

by Eugia US LLC

Reason
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Recall initiated
May 22, 2024
Reported by FDA
June 26, 2024
Distribution
USA nationwide.

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Drug Recall Ongoing Historical recordClass II

Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30

by Eugia US LLC

Reason
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Recall initiated
May 23, 2024
Reported by FDA
June 26, 2024
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

by Sagent Pharmaceuticals

Reason
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Recall initiated
May 28, 2024
Reported by FDA
June 19, 2024
Distribution
Nationwide within the USA.

View recall →

Drug Recall Ongoing Historical recordClass I

Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

by Sagent Pharmaceuticals

Reason
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Recall initiated
May 28, 2024
Reported by FDA
June 19, 2024
Distribution
Nationwide within the USA.

View recall →

Drug Recall Ongoing Historical recordClass III

Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-04

by Organon Llc

Reason
Defective Container
Recall initiated
May 28, 2024
Reported by FDA
June 19, 2024
Distribution
Nationwide in the USA

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.