Drug Alerts and Statements

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Alerts

See updates from CDER on fast-moving issues

Date	Title
11/1/2024	FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness
10/30/2024	Do not purchase or use Skin-Cap Aerosol Spray Products because they may be harmful to your health
10/2/2024	FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
9/26/2024	FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns
9/18/2024	FDA warns consumers not to use SnoreStop Nasal Spray by Green Pharmaceuticals due to potential contamination
9/5/2024	FDA warns consumers not to purchase or use Umary and Amazy products as they may be harmful to your health
8/6/2024	FDA warns consumers to not purchase or use unapproved inhalant products marketed for alertness and energy boosting
7/30/2024	FDA warns against purchasing or using chemical peel skin products without professional supervision
5/16/2024	FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection
4/29/2024	FDA alerts health care professionals of pregnancy problems associated with thiopurines
4/16/2024	Counterfeit Version of Botox Found in Multiple States
2/23/2024	FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)
1/31/2024	FDA warns consumers of contaminated copycat eye drops
1/17/2024	FDA announces shelf-life extension for naloxone nasal spray
12/27/2023	FDA requires updates to labeling for promethazine hydrochloride injection products
11/21/2023	FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks
11/3/2023	FDA warns consumers of hidden drug ingredients in Dr. Ergin’s SugarMD Advanced Glucose Support
10/27/2023	FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection
9/18/2023	FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsules
8/22/2023	FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination
8/1/2023	FDA warns consumers that Tydemy, a prescription oral contraceptive, may have reduced effectiveness
5/22/2023	G-Supress DX Pediatric Cough Drops may have incorrect drug in packaging
5/1/2023	FDA warns consumers to not purchase or use Nose Slap and Soul Slap products marketed for alertness and energy boosting
2/9/2023	Infants at risk for aluminum toxicity with unapproved potassium phosphates drug product
2/2/2023	FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination
11/22/2022	FDA alerts health care professionals of compatibility issues with prefilled glass syringes and certain Luer-activated valve (LAV) connectors
11/8/2022	FDA alerts health care professionals of risks to patients exposed to xylazine in illicit drugs
8/18/2022	FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection
4/29/2022	Bosentan REMS requirements will change June 27, 2022
4/26/2022	FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy
4/20/2022	FDA warns consumers not to purchase or use Artri and Ortiga products, which may contain hidden drug ingredients
3/30/2022	FDA warns patients and health care professionals not to use sterile products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding
9/17/2021	FDA alerts patients and health care professionals not to use compounded products intended to be sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy
7/28/2021	FDA alerts patients and health care professionals about clinical trial results showing an increased risk of death associated with Pepaxto (melphalan flufenamide)
3/19/2021	FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company)
1/15/2021	FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only
12/3/2020	FDA alerts healthcare professionals about the risk of medication errors with tranexamic acid injection resulting in inadvertent intrathecal (spinal) injection
9/21/2020	FDA alerts of Perrigo's voluntary albuterol inhaler recall
9/8/2020	FDA alerts health care professionals and oncology clinical investigators about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer
8/14/2020	FDA advises consumers not to use goldenseal root powder distributed by Maison Terre
7/2/2020	FDA warns consumers of risk of methanol contamination in certain hand sanitizers
6/19/2020	FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem
6/1/2020	FDA alerts patients and health care professionals of Amneal and Impax Laboratories epinephrine auto-injector device malfunctions
3/24/2020	FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration
10/11/2019	FDA advises consumers not to use Rompe Pecho cough syrup
7/23/2019	FDA advises patients not to use Herbal Doctor Remedies’ medicines
6/28/2019	FDA warns patients and health care professionals not to use sterile products from Pacifico National Inc., dba AmEx Pharmacy
6/25/2019	FDA alerts consumers not to use Kratom NC’s products
6/21/2019	FDA alerts patients and healthcare professionals to Infusion Options’ voluntary recall due to quality issues
2/12/2019	FDA alerts patients of McDaniel Life-Line’s voluntary recall of Indian Herb
2/1/2019	FDA warns compounders not to use glutathione from Letco Medical to compound sterile drugs
12/11/2018	FDA alerts consumers not to use two e-liquids sold by HelloCig Electronic Technology
12/7/2018	FDA alerts health care professionals and patients not to use drug products intended to be sterile from Promise Pharmacy
11/19/2018	FDA alerts health care professionals and patients not to use sterile drug products from Pharm D Solutions
11/8/2018	FDA alerts consumers of Kadesh Incorporation’s voluntary nationwide recall of Puriton Eye Relief Drops due to non-sterile production conditions
11/2/2018	FDA alerts patients and health care professionals that some EpiPen auto-injectors may not readily slide out of carrier tube
10/11/2018	FDA alerts consumers of Sprayology’s voluntary nationwide recall of homeopathic water-based medicines due to microbial contamination
10/4/2018	FDA alerts consumers and pet owners of Silver Star Brand's voluntary nationwide recall of homeopathic drug products
9/14/2018	FDA alerts consumers of BioLyte Laboratories voluntary recall of NeoRelief
9/14/2018	FDA alerts consumers not to use products distributed by Years to Your Health
9/7/2018	FDA alerts consumers of Beaumont Bio Med's voluntary recall of all water and alcohol-based products
8/31/2018	FDA alerts consumers of HelloLife's voluntary recall of Neuroveen, Respitrol, Thyroveev and Compulsin
8/17/2018	FDA alerts drug makers of a recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China
7/10/2018	FDA announces Ranier's Rx Laboratory voluntary recall of all sterile compounded drug
7/5/2018	FDA advises consumers not to use Blissful Remedies kratom products due to bacterial contamination
6/29/2018	FDA advises health care professionals not to use MedGyn Products Monsel's Solution
5/30/2018	FDA alerts health care professionals, patients, and the drug supply chain not to use stolen fertility drugs, Gonal-f RFF Redi-ject and Gonal-f Multi-Dose
4/13/2018	FDA alerts health care professionals to voluntary nationwide recall of all sterile products from Coastal Meds
3/30/2018	FDA alerts consumers of a nationwide voluntary recall of topical drug products made by Industria Farmacéutica Andrómaco due to contamination
3/16/2018	FDA is alerting consumers of a voluntary recall of Bayer's Alka-Seltzer Plus products due to labeling errors
3/16/2018	FDA warns consumers not to use unapproved erectile dysfunction products advertised on the radio
1/12/2018	FDA notifies health care professionals that Becton-Dickinson replaced problematic rubber stoppers in its syringes
10/27/2017	FDA updates on 2017 Burkholderia cepacia contamination
9/1/2017	FDA alerts health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes manufactured by Foshan Flying Medical Products
8/21/2017	FDA warns consumers about health risks of herbal coffee products from Malaysia containing undeclared active pharmaceutical ingredients and milk
8/10/2017	FDA alerts health care professionals and patients not to use sterile drug products from Vital Rx, dba Atlantic Pharmacy and Compounding
7/28/2017	FDA alerts health care professionals of adverse events associated with Guardian's compounded triamcinolone and moxifloxacin product for intravitreal injection
10/12/2016	FDA updates on multistate outbreak of burkholderia cepacia Infections
5/12/2016	FDA advises health care professionals that counterfeit BiCNU has been discovered in some foreign countries
4/15/2016	FDA alerts health care professionals not to use sterile drug products from Pharmakon Pharmaceuticals, Inc., Noblesville, Indiana
4/15/2016	FDA issues three new draft guidances related to compounding of human drugs
4/1/2016	FDA alerts health care professionals and patients not to use sterile drug products from Medaus Pharmacy, Birmingham, Alabama
3/30/2016	FDA announces voluntary recall of all unexpired compounded drug products produced by Reliable Rexall, San Francisco
3/23/2016	FDA warns consumers not to use "Best Bentonite Clay" laboratory tests indicate elevated levels of lead
3/14/2016	FDA alerts healthcare professionals about clinical trials with Zydelig (idelalisib) in combination with other cancer medicines
3/9/2016	FDA alerts health care professionals and patients not to use human and animal sterile drug products produced and distributed by I.V. Specialty, Ltd., Austin, Texas
2/16/2016	FDA announces Pharmakon Pharmaceuticals voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride
2/10/2016	FDA alerts compounding pharmacies of a nationwide voluntary recall of Syrspend SF and Syrspend SF Grape suspending agents from Fagron Inc., due to microbial contamination with yeast
1/28/2016	FDA warns consumers about health risks with Alikay Naturals - Bentonite Me Baby - Bentonite Clay
1/28/2016	FDA warns consumers not to use Viansilk's "Crema Piel De Seda" ("Silky Skin Cream")
1/15/2016	FDA warns consumers not to use Licorice Coughing Liquid
3/2/2018	FDA working with manufacturers to withdraw Zinbryta from the market in the United States

Statements

Learn about CDER's work to enhance public health

Date	Title
12/12/2024	CDER establishes new Center for Real-World Evidence Innovation
10/31/2024	FDA approves REMS modification, advancing new drug disposal option
10/02/2024	FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
9/24/2024	FDA's ISTAND Pilot Program accepts a submission of first organ-on-a-chip technology designed to predict human drug-induced liver injury (DILI)
6/20/2024	FDA updates guidance on interchangeability
6/14/2024	FDA issues agency-initiated proposed order regarding OTC monograph drugs containing acetaminophen
4/15/2024	FDA establishes CDER Center for Clinical Trial Innovation (C3TI)
3/25/2024	CDER Establishes New Quantitative Medicine Center of Excellence
3/15/2024	FDA Announces New Quality Oversight Webpage
3/11/2024	FDA issues guidance regarding drug development for early Alzheimer’s disease
1/29/2024	FDA revises letter of authorization for the emergency use authorization for Paxlovid
1/23/2024	FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience
12/21/2023	FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain
12/15/2023	FDA approves safety labeling changes for opioid pain medicines
10/17/2023	CDER soliciting comments regarding clinical trial innovation
9/21/2023	FDA issues guidance on using remote oversight tools to help approve drugs
9/18/2023	FDA issues draft guidance regarding confirmatory evidence of clinical trials
9/14/2023	FDA clarifies results of recent advisory committee meeting on oral phenylephrine
8/30/2023	DSCSA compliance policies establish 1-year stabilization period for implementing electronic systems
5/23/2023	FDA issues final guidance on adjusting for covariates in randomized clinical trials
5/17/2023	FDA issues two draft guidances for industry to support the approval of pediatric drug products
5/11/2023	FDA requires updates to clarify labeling of prescription stimulants used to treat ADHD and other conditions
4/28/2023	FDA issues final Nicotine Replacement Therapy Drug Products guidance
4/13/2023	FDA announces new safety label changes for opioid pain medicines
4/4/2023	FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19
3/29/2023	FDA launches Lupus Treatment Consortium in partnership with the Lupus Research Alliance
1/20/2023	FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems
11/30/2022	FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region
11/4/2022	FDA Updates on Bebtelovimab
10/21/2022	FDA issues final guidance about multiple endpoints in clinical trials
10/12/2022	FDA Announces Shortage of Adderall
10/6/2022	FDA Launches AATD Pre-Consortium Partnership with the Critical Path Institute
10/3/2022	FDA Expands CDER NextGen Portal
9/8/2022	FDA draft guidance aims to improve consistency of labeling for nonprescription drugs
9/7/2022	CDER and CBER accept first submission to ISTAND Pilot Program
9/1/2022	FDA initiates the Lysosomal Diseases Pre-Consortium at the Critical Path Institute
8/9/2022	FDA works to avoid shortage of sitagliptin following detection of nitrosamine impurity
5/10/2022	CDER launches new Accelerating Rare disease Cures (ARC) program
4/19/2022	FDA works to protect consumers from potentially harmful OTC skin lightening products
2/25/2022	FDA updates Sotrovimab emergency use authorization
2/24/2022	FDA authorizes revisions to Evusheld dosing
2/24/2022	Approved first generic for Apokyn injection cartridges requires separately packaged pen
1/26/2022	FDA issues series of guidances under Drug Competition Action Plan
1/12/2022	FDA warns about risks of dental problems associated with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain
12/23/2021	FDA Urges Manufacturers to Develop Solutions for iPLEDGE REMS Website
10/20/2021	FDA issues refuse-to-file letter for application for Barth syndrome
9/16/2021	FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19
7/30/2021	FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19
7/14/2021	FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or misleading promotional communications about the product’s benefit
7/2/2021	FDA alerts health care professionals and patients to a voluntary recall of varenicline (Chantix) to the warehouse level
5/19/21	FDA receives HHS grant to expand CURE ID platform for COVID-19 treatments
3/26/2021	CDER perspective on recently published results of EPPPIC meta-analysis
3/18/2021	FDA authorizes revisions to fact sheets to address SARS-CoV-2 variants for monoclonal antibody products under emergency use authorization
2/16/2021	FDA issues warning to AcelRx for making false and misleading claims about the risks and benefits of Dsuvia
12/10/2020	FDA will test ability to receive digital annotated ECG waveform files as agency prepares to transition to new ECG warehouse
12/4/2020	New studies show diabetes drug not proven to improve blood sugar control in pediatric patients
10/13/2020	FDA advises health care professionals and patients about insulin pen packaging and dispensing
10/5/2020	CDER proposes withdrawal of approval for Makena
8/26/2020	FDA works to mitigate shortages of rifampin and rifapentine after manufacturers find nitrosamine impurities
8/20/2020	FDA approves label changes to hydrochlorothiazide to describe small risk of non-melanoma skin cancer
3/19/2020	FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19
2/21/2020	FDA launches new resource to provide easily accessible, more accurate historical drug approval data
1/31/2010	FDA requests withdrawal of bacitracin for injection from market
1/30/2020	FDA revises generic drug application prioritization policy to ensure fairness to applicants, efficiently allocate limited agency resources, and protect the public health
7/5/2019	FDA issues guidance on compounding oral oxitriptan (5-HTP) for patients with tetrahydrobiopterin (BH4) deficiency
5/21/2019	FDA issues draft guidance for industry on the design and evaluation of comparative analytical studies for biosimilarity
5/2/2019	Communications with stakeholders concerning access to compounded oral oxitriptan for patients with tetrahydrobiopterin deficiency
4/29/2019	FDA reminds imaging facilities to follow safety procedures for rubidium 82 generators used in Positron Emission Tomography (PET) myocardial perfusion imaging
3/21/2019	FDA warns about the risks associated with the investigational use of Venclexta in Multiple Myeloma
9/26/2018	FDA announces new and expanded compounding research projects
9/20/2018	FDA analysis finds no new or unexpected safety risks associated with Nuplazid (pimavanserin), a medication to treat the hallucinations and delusions of Parkinson's disease psychosis
7/18/2018	FDA updates and press announcements on angiotensin II receptor blocker (ARB) recalls (Valsartan, Losartan, and Irbesartan)
6/28/2018	FDA approves labeling supplement for Celebrex (celecoxib)
6/21/2018	FDA withdraws draft guidance for industry: Statistical Approaches to Evaluate Analytical Similarity
5/22/2018	FDA video series about biosimilar and interchangeable products
5/18/2018	FDA alerts health care professionals and oncology clinical investigators about an efficacy issue identified in clinical trials for some patients taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as monotherapy to treat urothelial cancer with low expression of PD-L1
5/16/2018	FDA reports quality problems for data provided by the firm IQVIA that were used to inform estimates for some controlled substances
3/14/2018	FDA working with manufacturers to withdraw Zinbryta from the market in the United States
12/14/2017	FDA reminds pharmaceutical industry of new drug listing certification requirement due December 31, 2017
11/14/2017	FDA works to help relieve the IV fluid shortages in wake of Hurricane Maria
9/8/2017	FDA warns Meridian Medical Technologies about CGMP violations associated with the manufacture of EpiPen
8/31/2017	FDA alerts healthcare professionals and oncology clinical investigators about two clinical trials on hold evaluating KEYTRUDA® (pembrolizumab) in patients with multiple myeloma
8/4/2017	FDA warns consumers not to use Balguti Kesaria Ayurvedic Medicine due to high levels of lead
6/20/2017	FDA issues warning about body-building products labeled to contain steroid and steroid-like substances
5/22/2017	FDA advises drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug product
4/13/2017	FDA announces Standard Homeopathic Company's nationwide voluntary recall of Hyland's teething tablets
1/17/2017	FDA approves a generic of Xyrem with a REMS Program
1/12/2017	FDA issues final guidance on repackaging and revised draft guidance on mixing, diluting, and repackaging biological products
1/10/2017	FDA warns cancer patients not to use PNC-27 products for treatment
1/9/2017	Impact of exclusivity on approval of Arymo ER
12/28/2016	FDA issues guidance on prescription requirement under section 503A
12/28/2016	FDA issues draft guidances on compounding and repackaging radiopharmaceuticals
12/15/2016	FDA proposes six bulk drug substances for inclusion on the 503A bulks list
10/25/2016	FDA approves new changes to testosterone labeling regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS)
10/17/2016	Proposed rule to amend the list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety and effectiveness reasons
10/11/2016	FDA analyses conclude that Xarelto clinical trial results were not affected by faulty monitoring device
10/6/2016	Final rule amending list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety or effectiveness reasons
8/12/2016	FDA finds drugs under investigation in the U.S. related to French BIA 10-2474 drug do not pose similar safety risks
8/3/2016	FDA issues draft guidance on insanitary conditions at compounding facilities
7/8/2016	FDA approves a dedicated syringe to be used with Humulin R U-500 insulin
7/7/2016	FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs
6/9/2016	FDA issues final guidances on interim policy for certain bulk drug substances used in compounding
5/26/2016	Neonatal opioid withdrawal syndrome and medication-assisted treatment with methadone and buprenorphine
3/15/2016	FDA warns consumers about potential risks of using eye drops packaged in bottles with loose safety seals
1/22/2016	FDA works with regulatory partners to understand French-based Biotrial phase 1 clinical study

Archived Alerts and Statements 2010-2015

• FDA Archive 2014-2015
• FDA Archive 2010-2013