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FDA MedWatch Alerts

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...

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