689 recalls tagged with “fda regulated”.
Medline Industries recalled 22 sterile convenience kits on August 8, 2025, after discovering they had not been sterilized. The affected models include DYNJ0382730O and DYNJ61038B. This recall impacts states including Florida, Maryland, New Jersey, and Tennessee.
Glenmark Pharmaceuticals recalled 6,432 bottles of Carvedilol Tablets on August 7, 2025. The recall stems from CGMP deviations due to the presence of a nitrosamine impurity above acceptable levels. Consumers should stop using the product immediately and contact healthcare providers for guidance.
iForce Nutrition recalled 85,950 units of its Joint Help dietary supplement on August 6, 2025. The recall follows concerns over unapproved drug claims. Consumers should not consume the product and seek refunds.
Hi-Tech Pharmaceuticals recalled 85,950 units of its Taurine Mental & Athletic Performance dietary supplement on August 6, 2025. The company faces scrutiny for unapproved drug claims and misbranding. Consumers are urged to stop using the product immediately.
Hi-Tech Pharmaceuticals recalled 85,950 units of Quercetin dietary supplements on August 6, 2025. The recall stems from unapproved drug claims and misbranding. Consumers should stop using the product and seek refunds immediately.
The Candy Barn recalled 665 packages of Pecan Toffee Clusters on August 6, 2025. The recall stems from a labeling issue where pecans were not listed in the allergen statement. Consumers should not consume these products and seek refunds.
The Candy Barn recalled 665 packages of Chocolate Mint Fudge on August 6, 2025. The product lacks proper allergen labeling for egg, posing a risk to consumers. The fudge was distributed in Kalona, Iowa at two grocery locations.
Hi-Tech Pharmaceuticals recalled 85,950 units of its Battle Hardener dietary supplement on August 6, 2025. The product makes unapproved drug claims and poses a high health risk. Consumers should stop using the product immediately and contact the company for a refund.
Hi-Tech Pharmaceuticals recalled 85,950 units of its Joint-RX dietary supplement on August 6, 2025. The recall occurred due to unapproved drug claims related to the product. Consumers should not consume this supplement and should seek refunds or replacements.
Hi-Tech Pharmaceuticals recalled 85,950 units of its Phytoform Fruits & Greens Formula on August 6, 2025, due to unapproved drug claims. The product, sweetened with monk fruit and flavored kiwi-strawberry, poses health risks from misleading labeling. Consumers should not consume the product and seek refunds immediately.
Hi-Tech Pharmaceuticals recalled 85,950 units of its Phytoform Fruits & Greens Formula on August 6, 2025. The product contains unapproved drug claims and is misbranded. Consumers should stop using the product immediately and seek a refund.
Glenmark Pharmaceuticals recalled 17,496 bottles of Carvedilol Tablets on August 6, 2025. Tests revealed N-Nitroso Carvedilol Impurity-1 levels exceeded FDA limits. Consumers should stop using the medication immediately.
Westminster Pharmaceuticals recalled 4,456 bottles of Metoprolol Tartrate Tablets on August 6, 2025. The recall follows the detection of a nitrosamine, N-nitroso-metoprolol, above acceptable daily intake levels. Consumers should immediately stop using this medication and consult healthcare providers.
The Candy Barn recalled 665 packages of English Toffee on August 6, 2025. The product contains undeclared pecans, posing a risk to those with tree nut allergies. Consumers should not eat the candy and should seek a refund or replacement.
The Candy Barn recalled 665 packages of its Chocolate Fudge on August 6, 2025. The product does not list egg in the allergen statement, posing a risk to those with egg allergies. Consumers should not consume the product and seek a refund.
Sandoz Inc. recalled 10 bags of Enoxaparin Sodium Injection on August 5, 2025. Bags labeled for Enoxaparin Sodium 80 mg/0.8 mL contained the incorrect dosage of 30 mg/0.3 mL. Consumers and healthcare providers must stop using the product immediately.
Hospira, Inc. recalled 49,620 vials of Epinephrine Injection on August 4, 2025. The recall follows concerns about the lack of assurance of sterility. Consumers should stop using the product immediately.
DFA Dairy Brands recalled 54 cases of Friendly's Ice Cream on August 1, 2025. The product contains undeclared wheat and soy, posing a serious allergen risk. Consumers in Maryland, Virginia, and Pennsylvania should not consume the affected ice cream.
Waldemar Link GmbH & Co. KG recalled eight units of the LinkSymphoKnee Tibial Component on July 31, 2025. The recall stems from a manufacturing error involving uncoated security screws. Patients and healthcare providers should stop using the device immediately.
Exela Pharma Sciences recalled 4.2% Sodium Bicarbonate Injection on July 30, 2025, due to arsenic contamination. The recall affects single-dose vials distributed nationwide. Consumers and healthcare providers must stop using the product immediately.