Drug Safety Alerts
Consumer-oriented pharmaceutical informationDrug Safety Alerts
The Food and Drug Administration (FDA) routinely publishes a variety of alerts on its MedWatch system related to safety issues with pharma products.
The agency receives complaints and other safety-related information from health care providers, manufacturers, and consumers on Medwatch, as well as notifications of safety issues from manufacturers.
When the FDA deems it to be appropriate based on the severity of the issue, the volume of complaints or other factors, it will issue a warning or safety alert to health care providers and the public, which is often accompanied by a recall notice issued by the manufacturer to remove affected products from the market.
Warnings and safety alerts can include:
- Product issues.
- Ancillary issues that can be a safety hazard, such as labeling.
- Recalls.
- Any other information related to a negative effect on the safe use of a product.
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FDA Drug Safety Alerts
| Date | Alert | More information |
|---|---|---|
| 1/16/2025 | FDA warns health care professionals not to use epinephrine nasal solutions from BPI Labs and Endo USA | Safety Communication |
| 11/1/2024 | FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness | Safety Communication |
| 10/30/2024 | Do not purchase or use Skin-Cap Aerosol Spray Products because they may be harmful to your health | Safety Communication |
| 10/2/2024 | FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize | Safety Communication |
| 9/26/2024 | FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns | Safety Communication |
| 9/18/2024 | FDA warns consumers not to use SnoreStop Nasal Spray by Green Pharmaceuticals due to potential contamination | Safety Communication |
| 9/5/2024 | FDA warns consumers not to purchase or use Umary and Amazy products as they may be harmful to your health | Safety Communication |
| 8/6/2024 | FDA warns consumers to not purchase or use unapproved inhalant products marketed for alertness and energy boosting | Safety Communication |
| 7/30/2024 | FDA warns against purchasing or using chemical peel skin products without professional supervision | Safety Communication |
| 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 | Safety Communication |
| 4/29/2024 | FDA alerts health care professionals of pregnancy problems associated with thiopurines | Safety Communication |
| 4/16/2024 | Counterfeit Version of Botox Found in Multiple States | Safety Communication |
| 2/23/2024 | FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide) | Safety Communication |
| 1/31/2024 | FDA warns consumers of contaminated copycat eye drops | Safety Communication |
| 1/17/2024 | FDA announces shelf-life extension for naloxone nasal spray | Safety Communication |
| 12/27/2023 | FDA requires updates to labeling for promethazine hydrochloride injection products | Safety Communication |
| 11/21/2023 | FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks | Safety Communication |
| 11/3/2023 | FDA warns consumers of hidden drug ingredients in Dr. Ergin’s SugarMD Advanced Glucose Support | Safety Communication |
| 10/27/2023 | FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection | Safety Communication |
| 9/18/2023 | FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsules | Safety Communication |
| 8/22/2023 | FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination | Safety Communication |
| 8/1/2023 | FDA warns consumers that Tydemy, a prescription oral contraceptive, may have reduced effectiveness | Safety Communication |
| 5/22/2023 | G-Supress DX Pediatric Cough Drops may have incorrect drug in packaging | Safety Communication |
| 5/1/2023 | FDA warns consumers to not purchase or use Nose Slap and Soul Slap products marketed for alertness and energy boosting | Safety Communication |
| 2/9/2023 | Infants at Risk for Aluminum Toxicity with Unapproved Potassium Phosphates Drug Product | Safety Communication |
| 2/2/2023 | FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination | Safety Communication |