- FDA Advises Consumers Not to Inhale Nitrous Oxide Products
Audience: Consumer, Health Professional, Pulmonology March 14, 2025 -- FDA advises consumers not to inhale nitrous oxide products from any size canisters, tanks, or chargers. These products are marketed as both unflavored and flavored nitrous oxide...
- 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
Audience: Pharmacy, Health Care Professional March 13, 2025 -- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), is...
- Limited Number of Voluntary Recalls Initiated after FDA Testing of Acne Products for Benzene
Audience: Consumer, Pharmacy March 11, 2025 -- FDA is alerting the public and industry to the results of new agency testing of 95 acne products containing benzoyl peroxide for possible benzene contamination. FDA has concluded that a limited number...
- Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) Due to Increased Reports of Allergic/Hypersensitivity Reactions
Audience: Patient, Health Professional, Pharmacy, Immunology March 10, 2025 -- As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the...
- One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil
Audience: Consumer Benton, Arkansas – 03/03/2025 –One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the Consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which...
- Natural Dior LLC Issues Voluntary Nationwide Recall of Vitafer-L Gold Liquid Due to Presence of Undeclared Tadalafil
Audience: Consumer Natural Dior LLC (USA) – February 25, 2025 – Natural Dior LLC, is voluntarily recalling the affected lots of Vitafer-L Gold Liquid, a dietary supplement with iron and vitamins, to the consumer level. The...
- CAPS Issues 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
Audience: Pharmacy, Health Care Professional February 24, 2025 – Bethlehem, PA. Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags (NDC: 71285-6092-1) to the...
- ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling
Audience: Consumer, Health Professional, Pharmacy February 13, 2025 LAKE FOREST, Illinois – ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM...
- Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System
Audience: Consumer, Health Professional, Pharmacy January 31, 2025 – Morristown, NJ -- Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall...
- Provepharm Inc. Issues Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter
Audience: Pharmacy, Consumer January 24, 2025 – Collegeville, Pennsylvania, Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk...
- Drug Safety Communication: Copaxone, Glatopa (glatiramer acetate) - FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis
Audience: Patient, Caregiver, Health Care Professional, Pharmacy, Neurology ISSUE: The FDA is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used to treat patients...
- FDA Warns Health Care Professionals Not to Use Epinephrine Nasal Solutions from BPI Labs and Endo USA
Audience: Health Care Professionals January 16, 2025 -- FDA is warning health care professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, in Largo, Fla., and Endo USA, in Malvern, Pa. Health care professionals...
- FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy
Audience: Patient, Health Care Professional, Pharmacy, Immunology, Pulmonology ISSUE: FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc...
- Astellas Issues Recall of One Lot of Prograf 0.5 mg and One Lot of Astagraf XL 0.5 mg Because Bottles Shipped to U.S. May Contain Empty Capsules
Audience: Healthcare Provider, Pharmacy, Consumer NORTHBROOK, IL, Dec. 23, 2024 – Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, "Astellas") is voluntarily recalling one lot of Prograf® 0.5mg (tacrolimus) and one lot...
- Alcon Laboratories Issues Voluntary Nationwide Recall of One Lot of Systane Lubricant Eye Drops Ultra PF Due to Fungal Contamination
Audience: Healthcare Provider, Pharmacy, Consumer December 21, 2024 – Fort Worth, Texas. Alcon Laboratories is voluntarily recalling one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) to the...
- Endo USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the Potential for Administration Errors
Audience: Healthcare Professional, Pharmacy, Consumer MALVERN, PA, December 20, 2024 – Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling all lots...
- Shoppers-Plaza Issues Voluntary Nationwide Recall of Fouzee Sugarlin Herbal Formula Due To Presence Of Undeclared Metformin And Glyburide
Audience: Consumer December 16, 2024 – Los Angeles, California - Shoppers-Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the consumer level. See below for photo of product labeling. Fouzee Sugarlin Herbal...
- FDA Adds Boxed Warning to Veozah (fezolinetant) to Highlight the Known Risk of Rare But Serious Liver Injury
Audience: Patient, Health Professional, OBGYN, Endocrinology Update: December 16, 2024FDA adds a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury associated with use of menopause medicine Veozah...
- Drug Safety Communication: Ocaliva (obeticholic acid) - Serious Liver Injury Being Observed in Patients without Cirrhosis
Audience: Gastroenterology, Hepatology, Patient, Health Care Professional, Pharmacy ISSUE: The FDA identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did...
- Buy-herbal.com Issues Voluntary Nationwide Recall of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules Due to Undeclared Furosemide, Dexamethasone and Chlorpheniramine
Audience: Consumer Flushing, New York, Buy-herbal.com is voluntarily recalling all lots within expiry of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules to the consumer level. FDA analysis has found these products to contain undeclared Furosemide...
- FDA Investigating Serious Risk of Hematologic Malignancy Following Skysona (elivaldogene autotemcel)
Audience: Health Professional November 27, 2024 -- Since approval, the Food and Drug Administration (FDA) has received additional reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome and acute myeloid...
- Mxbbb Issues Voluntary Nationwide Recall of Umary Acid Hyaluronic Due to the Presence of Diclofenac and Omeprazole
Audience: Healthcare Provider, Pharmacy, Consumer November 20, 2024 -- MXBBB is voluntarily recalling 1 lot of UMARY ACID HYALURONIC, 30 CAPLETS 850 MG to the consumer level. The products have been found to have omeprazole and diclofenac. FDA...
- Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling
Audience: Healthcare Provider, Pharmacy, Consumer November 19, 2024 -- Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of...
- VitalityVita Issues Voluntary Nationwide Recall of VitalityXtra and PeakMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac
Audience: Consumers November 4, 2024 – Sacramento, CA, VitalityVita.com is voluntarily recalling lot 230811, Exp 8/11/25, of VitalityXtra Capsules and PeakMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level...
- Boulla LLC Issues Voluntary Nationwide Recall of ZoomMax and ZapMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac
Audience: Consumers November 4, 2024 – Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. The...