What is a drug recall?
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. A drug recall occurs when a medication is removed from the market because the medication is deemed to be defective or possibly harmful. A market withdrawal occurs when a product has a minor violation that would not be subject to FDA legal action. The company removes the product from the market or corrects the problem. The FDA issues a notification to inform healthcare providers, hospitals, and wholesalers about medication safety issues or concerns.
L.A. Care works closely with pharmacies and providers to make sure the medications you take are safe. When we are notified that a medication has a potential problem, we will notify you and your prescriber right away.
What are the types of drug recalls?
Drug recalls are categorized according to the seriousness of the potential harms.
- Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
- Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
- Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
Specific drug recalls are listed in the sidebar to your right for your convenience. If you are taking a medication that has been recalled or withdrawn from the market, talk to your health care provider right away about the best course of action for you.
FDA Recall Notification
Get access to specific drug recalls and their dates below:
- Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion Bag
Recall Date: 3/13/2025 - One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil
Recall Date: 3/3/2025
- Natural Dior LLC Issues Voluntary Nationwide Recall of Vitafer-L Gold Liquid Due to Presence of Undeclared Tadalafil
Recall Date: 2/25/25 - Ascent Consumer Products Inc. Issues Voluntary Nationwide Recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Due to Microbial Contamination
Recall Date: 2/25/25 - Central Admixture Pharmacy Services (CAPS) Issues Nationwide Recall of Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags Due to Visible Black Particulate Matter in a Single-Sealed Vial
Recall Date: 2/24/25 - One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil
Recall Date: 2/20/25 - BD Announces Voluntary Worldwide Recall for One Lot of ChloraPrep™ Clear 1 mL Applicators Due to Fungal Contamination
Recall Date: 2/18/25 - ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling
Recall Date: 2/14/25
- Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System
Recall Date: 1/31/25 - Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter
Recall Date: 1/24/25