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 If you are taking a medication that has been recalled or withdrawn from the market, talk to your health care provider right away about the best course of action for you.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:
- Aurobindo Pharma USA, Inc. on Behalf of AuroHealth, Issues Voluntary Nationwide Recall of one (1) Lot of Healthy Living Over the Counter (OTC) Migraine Relief: Acetaminophen 250mg; Aspirin 250mg; Caffeine 65mg Tablets, Due to Missing Manufacturer Label
Recall Date: 7/24/24 - Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of One Lot of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) Bags Due to an Individual Unit of Acetaminophen Overwrap Found to Have Contained a Labelled Bag of Dexmedetomidine HCL Injection (400mcg/100mL)
Recall Date: 7/22/24 - Main Products, Inc. Issues Voluntary Nationwide Recall of Umary Acido Hialuronico, Suplemento Alimenticio Due to the Presence of Undeclared Drug Ingredients: Diclofenac and Omeprazole
Recall Date: 7/22/24 - Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 Due to Mislabeling: Incorrect Strength on Product Carton
Recall Date: 7/17/24 - GURU INC. Issues Voluntary Nationwide Recall of Infla-650 Herbal Dietary Supplement Capsules Due to Hidden Drug Ingredients
Recall Date: 7/16/24 - SoloVital.com Issues Voluntary Nationwide Recall of Umary Acido Hialuronica, Suplemento Alimenticio 850 mg Capsules Due to the Presence of Undeclared Drug Ingredients: Diclofenac and Omeprazole
Recall Date: 7/15/24 - Supercore Products Group, Inc. Issues Voluntary Worldwide Recall of Hard Steel Capsules & Gold Hard Steel Plus Liquid Due to the Presence of Sildenafil and Acetaminophen
Recall Date: 7/12/24
- American Health Packaging on Behalf of BluePoint Laboratories Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
Recall Date: 6/26/24 - Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
Recall Date: 6/25/24 - Suntegrity Skincare Issues Voluntary Recall of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) Due to Microbial Contamination
Recall Date: 6/12/24 - Male Enhancement Supplements Recalled
Recall Date: 6/11/24 - HomeoCare Laboratories Inc. Issues Voluntary Nationwide Recall of Homeopathic Stella Life Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse Due to Microbial Contamination
Recall Date: 6/5/24
- Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP Due to Potential Presence of Particulate Matter Recall Date: 5/29/24
- Hospira Inc. Issues A Voluntary Nationwide Recall For Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units Due to the Potential for Incomplete Crimp Seals
Recall Date: 5/21/24