Drug Alerts and Statements

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Alerts

See updates from CDER on fast-moving issues

Date	Title
2/10/2025	FDA Alerts Healthcare Professionals About the Risk of Medication Errors with Tranexamic Acid Injection Resulting in Inadvertent Intrathecal (Spinal) Injection
1/16/2025	FDA warns health care professionals not to use epinephrine nasal solutions from BPI Labs and Endo USA
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
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
4/17/2024	FDA warns consumers of risk of methanol contamination in certain hand sanitizers
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
11/8/2022	FDA alerts health care professionals of risks to patients exposed to xylazine in illicit drugs

Statements

Learn about CDER's work to enhance public health

Date	Title
4/27/2026	CDER proposes to withdraw approval of TAVNEOS
4/16/2026	First FDA-Approved Treatment for Patients with Focal Segmental Glomerulosclerosis—A Rare Kidney Condition
4/7/2026	FDA Approves First Generic Dapagliflozin Tablets
3/3/2026	FDA Approves First Generic of Flovent HFA for Treatment of Asthma
1/21/2026	FDA Announces PreCheck Implementation Roadmap
12/19/2025	FDA Qualifies Total Hip Bone Mineral Density (BMD) as Surrogate Endpoint for Osteoporosis Drug Development
12/8/2025	FDA Approves First Generic Estradiol Vaginal Insert for Treatment of Moderate to Severe Dyspareunia
12/8/2025	FDA Qualifies First AI Drug Development Tool, Will Be Used in 'MASH' Clinical Trials
11/24/2025	FDA Approves Reformulated Ranitidine Following Comprehensive Safety Review
11/10/2025	FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies
10/10/2025	FDA’s actions to protect children from contaminated cough medicine
10/03/2025	FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing
8/27/2025	FDA accepts proposal for reasonably likely surrogate endpoint for ‘MASH’ all-cause mortality or liver-related events
3/11/2025	Limited number of voluntary recalls initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contamination
2/28/2025	FDA issues class-wide labeling changes for testosterone products
2/14/2025	FDA qualifies drug development tool to facilitate clinical trial research on alcohol use disorder
12/26/2024	FDA recommends changes to labeling for transmucosal buprenorphine products indicated to treat opioid use disorder
12/23/2024	FDA issues final rule to broaden types of nonprescription drugs available to consumers
12/12/2024	CDER establishes new Center for Real-World Evidence Innovation
10/31/2024	FDA approves REMS modification, advancing new drug disposal option
4/1/2026	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

Archived Alerts and Statements 2010-2025

• FDA Archive 2016-2025
• FDA Archive 2014-2015
• FDA Archive 2010-2013