FDA MedWatch Alerts
FDA Warns Consumers Not to Purchase or Use Umary and Amazy Products As They May Be Harmful To Your Health
September 5, 2024 -- FDA is warning consumers not to purchase or use Umary and Amazy products, marketed as dietary supplements, as they may be harmful to your...
Veata LLC Issues Voluntary Nationwide Recall of Endurance Pro Capsules Due to the Potential Presence of Undeclared Sildenafil
August 14, 2024 – Sacramento CA, Veata LLC is voluntarily recalling lot 230811, Exp 8/11/25 of Endurance Pro Energy Boost capsules, packaged in 10-count...
Boulla LLC Issues Voluntary Nationwide Recall of Boom Max Capsules Due to the Potential Presence of Undeclared Sildenafil
August 14, 2024 – Sacramento CA, Boulla LLC is voluntarily recalling lot number 230811, exp 8/11/25 of Boom Max capsules packaged in 10-count blisters...
B. Braun Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 Containers Due to the Potential for Particulate Matter and Leakage
BETHLEHEM, PA - August 8, 2024 – B. Braun Medical Inc. (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000...
FDA Warns Consumers to Not Purchase or Use Unapproved Inhalant Products Marketed for Alertness and Energy Boosting
August 6, 2024 -- FDA is warning consumers to not purchase or use certain inhalants, which are unapproved drugs marketed to promote alertness and boost...
Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium in 0.9% Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels
DEERFIELD, Ill., AUG. 5, 2024 – Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection...
FDA Warns Against Purchasing or Using Chemical Peel Skin Products Without Professional Supervision
July 30, 2024 -- FDA is warning consumers not to purchase or use certain chemical peel skin products without appropriate professional supervision due to risk...
Main Products, Inc. Issues Recall of Umary Acido Hialuronico, Suplemento Alimenticio Due to the Presence of Undeclared Drug Ingredients
July 22, 2024 – Chula Vista, CA – Main Products, Inc. is voluntarily recalling all lots of “Umary Acido Hialuronico, Suplemento...
Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of One Lot of Acetaminophen Injection, 1000mg/100mL (10mg/mL) Bags
London, July 22, 2024 – Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA, Inc. is extending its...
Aurobindo Pharma USA, Inc. on Behalf of AuroHealth, Issues Recall of One Lot of Healthy Living Over the Counter (OTC) Migraine Relief
July 18, 2024 – East Windsor, New Jersey. Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot (refer table below) of...
Endo USA, Inc. Issues Recall of One Lot of Clonazepam Orally Disintegrating Tablets Due to Mislabeling: Incorrect Strength on Product Carton
MALVERN, PA, July 16, 2024 – Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA...
GURU INC. Issues Voluntary Nationwide Recall of Infla-650 Herbal Dietary Supplement Capsules Due to Hidden Drug Ingredients
Lilburn, GA, July 16, 2024 -- GURU INC. is voluntarily recalling Infla-650 Herbal Dietary Supplement Capsules, Lot No. IN-032, 700 mg to the consumer/user...
FDA, FTC Continue Joint Effort to Protect Consumers Against Companies Illegally Selling Copycat Delta-8 THC Food Products
July 16, 2024 -- Today, the U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued warning letters to five companies for illegally...
Supercore Issues Voluntary Worldwide Recall of Hard Steel Capsules & Gold Hard Steel Plus Liquid Due to the Presence of Sildenafil and Acetaminophen
Atlanta, GA -- July 12, 2024 -- Supercore Products Group is voluntarily recalling of Hard Steel Capsules & Gold Hard Steel Plus Liquid to the consumer...
Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare Delivery System
June 26, 2024 -- Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize...
American Health Packaging on Behalf of BluePoint Laboratories Issues Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
June 25, 2024 – American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release...
Glenmark Pharmaceuticals Inc., USA Issues Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
June 24, 2024 – Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP...
Male Enhancement Supplements Recalled
June 11, 2024 -- Integrity Products , St Louis MO is voluntarily recalling tainted lot (HGW221116) within expiry of the Ram It & To The Moon capsules to...
Penn Herb Company Ltd Recalls Nature’s Wonderland Thyroid Formula Because of Possible Health Risk
June 11, 2024 -- Penn Herb Company Ltd of Philadelphia, Pennsylvania is recalling 51 bottles (60 Capsules per bottle) of Nature’s Wonderland Thyroid...
HomeoCare Laboratories Inc. Issues Recall of Stella Life Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse Due to Microbial Contamination
Yonkers, NY, 06/05/2024 – HomeoCare Laboratories Inc., a manufacturer of homeopathic products, is voluntarily recalling two batches of Homeopathic...
Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP Due to Potential Presence of Particulate Matter
SCHAUMBURG, IL – May 28, 2024 – Sagent Pharmaceuticals today announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80...
Hospira Inc. Issues Voluntary Recall for Buprenorphine HCl Injection Carpuject Units and Labetalol HCl Injection Carpuject Units Due to Potential for Incomplete Crimp Seals
May 21, 2024 - NEW YORK, NY., Hospira, Inc., a Pfizer company (“Pfizer”), is voluntarily recalling the lots listed in the table below of...
Cross-Compatibility Issues with Autoinjector Devices Optional for Use with Glatiramer Acetate Injection
May 16, 2024 -- FDA is alerting patients, caregivers, and health care professionals of labeling updates for glatiramer acetate injection products. Updated...
FDA Safety Communication: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results
May 13, 2024 -- The U.S. Food and Drug Administration (FDA) is warning home test users, caregivers, and health care providers not to use Cue Health’s...
FDA Alerts Health Care Professionals of Pregnancy Problems Associated with Thiopurines
April 29, 2024 -- FDA is alerting health care professionals of the rare risk of intrahepatic cholestasis of pregnancy (ICP) associated with the use of...
Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency
Hyderabad India and Princeton, NJ, US; April 23, 2024 – Dr. Reddy's Laboratories Ltd. today announced that it is voluntarily recalling six (6) lots of...
Stop Clopez Corp. Issues Voluntary Worldwide Recall of Schwinnng Capsules Due to the Presence of Undeclared Nortadalafil
April 22, 2024– Hollywood, FL, US, Stop Clopez Corp. is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has found...
FDA Requires Boxed Warning for T Cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous CAR T Cell Immunotherapies
April 18, 2024 -- In November 2023, the Food and Drug Administration (FDA) posted a safety communication to provide information about reports of T cell...
Counterfeit Versions of Botox Found in Multiple States
April 16, 2024 -- FDA is alerting health care professionals and consumers that unsafe counterfeit versions of Botox (botulinum toxin) have been found in...
Otsuka Initiates Voluntary Nationwide Recall of Certain Lots of Abilify (aripiprazole) Tablets Due to Drug Product Cross-Contamination on Manufacturing Equipment
PRINCETON, N.J. (April 9, 2024) – Otsuka America Pharmaceutical, Inc. (Otsuka) is voluntarily recalling certain Abilify (aripiprazole) Tablets in the...
Aruba Aloe Balm N.V. Issues Voluntary Nationwide Recall of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel Due to Presence of Methanol
April 5, 2024 – Oranjestad, Aruba, Aruba Aloe Balm N.V. is voluntarily recalling 40 lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe...
ForeverMen Supplements Recalled
April 2, 2024 -- FAonline INC , 65-20 180 Street NY 11365 is voluntarily recalling all lots within expiry of the ForeverMen capsules to the consumer level. FDA...
AvKARE, LLC. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5 mL Due to Potential Bacillus Cereus Contamination
March 29, 2024 –AvKARE, LLC is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the...
Eugia US LLC Issues Voluntary Nationwide Recall of Methocarbamol Injection, USP 1000 mg/10 mL Due to Presence of White Particles
March 28, 2024– East Windsor, New Jersey, Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of...
Amneal Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL Due to the Potential for Some Bottles to be Super Potent
March 27, 2024 - Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride...
FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects
March 26, 2024 -- The U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are...
Pyramid Wholesale Issues Recall of Various Brands of Products Sold as Dietary Supplements for Sexual Enhancement
March 19, 2024, Los Angeles, CA – Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement...
Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates
March 12, 2024 – DUBLIN, Ireland – Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is...
Brassica Pharma Pvt. Ltd. Issues Voluntary Nationwide Recall of Eye Ointment Products Due to Potential Lack of Sterility
22 February, 2024 – Thane, Maharashtra, India, Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with...
Nordic Naturals Issues Voluntary Recall of Baby's Vitamin D3 Liquid Due to Elevated Levels of Vitamin D3
Watsonville, Calif. (Feb. 17, 2024) – Nordic Naturals is voluntarily recalling one lot of Nordic Naturals Baby’s Vitamin D3 Liquid, 0.76 fl. oz...
FDA Safety Communication: Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist
Update: February 6, 2024 Additional Related Recalls of Saline and Sterile Water Medical Products Associated with Nurse Assist In direct response to the Nurse...
Today The World Issues Voluntary Nationwide Recall of All Lots of Sustain and Schwinnng brand Dietary Supplement Capsules Due to the Presence of Undeclared Tadalafil and Nortadalafil
February 2, 2024 - VANCOUVER, WA, "Today The World" is voluntarily recalling two lots of Sustain herbal dietary supplement capsules and one lot of Schwinnng...
Today The World Issues Voluntary Nationwide Recall of All Lots of Arize Herbal Dietary Supplement Capsules Due to the Presence of Undeclared Nortadalafil
Feb 2, 2024 - VANCOUVER, WA, “Today The World” is voluntarily recalling one lot of Arize Herbal Dietary Supplement capsules to the consumer level...
Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid Due to the Presence of Benzene
TARRYTOWN, N.Y.--(GLOBE NEWSWIRE)-February 1, 2024—Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is...
FDA Warns Consumers of Contaminated Copycat Eye Drops
January 31, 2024 -- FDA is warning consumers not to purchase or use South Moon, Rebright or FivFivGo eye drops because of the potential risk of eye...
Neptune Resources, LLC Issues Voluntary Nationwide Recall of Neptune’s Fix
KANSAS CITY, Mo., Jan. 28, 2024 /PRNewswire-PRWeb/ -- Neptune Resources, LLC is voluntarily recalling All lots of Neptune's Fix Elixir, Neptune's Fix Extra...
Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing
January 24, 2024 – Woburn, Massachusetts, Azurity Pharmaceuticals, Inc. is voluntarily recalling one (1) lot (F230169A) of Zenzedi® CII...
Haleon Issues Voluntary Nationwide Recall of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products Due to Microbial Contamination
January 24, 2024 – Warren, NJ, Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime...
Update: FDA Warns Consumers Not to Purchase or Use Neptune’s Fix or Any Tianeptine Product Due to Serious Risks
January 23, 2024 -- FDA continues to receive severe adverse event reports after use of Neptune‘s Fix products, including seizures, loss of consciousness...
Drug Safety Communication: Prolia (denosumab) - FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease
January 19, 20204 -- Based on a completed FDA review of available information, FDA has concluded that the osteoporosis medicine Prolia (denosumab) increases...
Kilitch Healthcare India Limited Issues Amendments in Last Voluntary Nationwide Recall Press Release
The firm issued a press release on 11/15/2023. This press release amendment includes corrected NDC numbers for the mentioned products. January 05, 2024&ndash...
Drug Safety Communication: Certain Type of Medicines Approved for Type 2 Diabetes and Obesity - Update on FDA’s Ongoing Evaluation of Reports of Suicidal Thoughts or Actions
ISSUE: The FDA has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1...
Leiters Health Issues Voluntary Nationwide Recall of Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Due to Potential for Superpotent Drug
January 5, 2024 – Englewood, Colorado, Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches...
FDA MedWatch Alerts archive
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
More news resources
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.