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.
Urgent Recall Alert for Methocarbamol Injection by Eugia US LLC
Attention Consumers, Healthcare Providers, and Distributors: Eugia US LLC, formerly known as AuroMedics Pharma LLC, announced a voluntary recall on March 28, 2024 of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) 10mL Single Dose Vial....
Amneal Recalls Vancomycin Hydrochloride Oral Solution
Some bottles may be super potent Attention Patients, Health Professionals, and Pharmacies: Amneal Pharmaceuticals issued a safety notice on March 27 for a recall of specific lots of Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL. This recall has been...
FDA Drug Safety Alerts
| Date | Subject | More information |
|---|---|---|
| 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 |