Drug Alerts and Statements

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• Statements

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