1,264 recalls tagged with “fda regulated”.
SUNGAL Inc. recalls 29 cases of UDK Half Plum, 170 g containers distributed to California, Maryland, New York and Virginia. The product is adulterated with cyclamate. Consumers should not consume it and should email SUNGAL Inc. for refund or replacement information.
Medline Industries, LP recalled 22 sterile convenience kits distributed to Florida, Maryland, New Jersey and Tennessee after determining the kits labeled as sterile had not undergone sterilization. The sterility lapse creates an infection risk for patients. Healthcare facilities and patients should stop using the kits and follow the recall instructions from Medline and the FDA.
Medline Industries recalled 88 units of the Sterile Extremity Pack DYNJ45701B after finding that kits labeled as sterile had not undergone sterilization. The affected distribution covered Florida, Maryland, New Jersey and Tennessee. Hospitals and clinics should stop using the kit immediately and follow Medline's recall instructions.
Glenmark Pharmaceuticals Inc. recalls 6,432 bottles of Carvedilol Tablets, USP, 12.5 mg, distributed nationwide in the United States. The recall concerns CGMP deviations and the presence of a nitrosamine impurity above the acceptable intake level. Consumers should stop taking the product and contact Glenmark for guidance.
Glenmark Pharmaceuticals recalls 4,800 bottles of Carvedilol 25 mg tablets distributed nationwide in the USA. The recall cites CGMP deviations and a nitrosamine impurity exceeding the Acceptable Intake Level. Consumers should stop using the product and contact Glenmark or their healthcare provider for guidance.
Monica Vinader recalls select 14k yellow gold mini heart bracelets, necklaces and stud earrings due to high cadmium levels. The recalled jewelry was manufactured in October and November 2024. Consumers should stop wearing the jewelry immediately and contact Monica Vinader for a replacement or refund.
Glenmark Pharmaceuticals Inc. recalls 44,328 bottles of Carvedilol tablets, 3.125 mg, distributed nationwide in the USA. The impurity N-nitroso carvedilol I exceeds the Acceptable Intake Level. Consumers should stop using the product and contact Glenmark for guidance.
Wang Globalnet recalled 1,705 cases of frozen raw oyster halves sold at 27 retail locations in the Northeast and Southwest. The two lots, B250103 and B250114, are under recall for potential Norovirus contamination. Consumers should not consume these oysters and should contact Wang Globalnet for refunds or replacements.
Hi-Tech Pharmaceuticals recalled 85,950 units of PrimeNutrition Taurine Mental & Athletic Performance dietary supplement distributed nationwide. The FDA enforcement report cites unapproved drug claims and misbranding. Consumers who purchased this product should not consume it and should contact the company for refund or replacement.
Hi-Tech Pharmaceuticals recalled 85,950 units of PrimeNutrition PhytoForm Fruits & Greens Formula after FDA enforcement flagged unapproved drug claims and misbranding. The dietary supplement was distributed to 40+ states before the recall was issued on 2025-08-06 and remains active. Consumers should not consume the product and should seek refund or replacement from Hi-Tech Pharmaceuticals.
Olympus Corp of the Americas recalled 103,731 ViziShot 2FLEX single-use aspiration needles worldwide after officials flagged potential undetected, deformed atraumatic tips. The recall covers the NA-U403SX-4019 model. Healthcare providers must halt use immediately and follow manufacturer instructions for recall. Manufacturers say notification was by letter.
Hi-Tech Pharmaceuticals recalled 85,950 units of iFORCE Joint Help Healthy Joints & Ligaments Dietary Supplement after regulators flagged unapproved drug claims. The product was distributed to 50 states. Consumers should stop using the product and contact Hi-Tech Pharmaceuticals for refund or replacement.
Westminster Pharmaceuticals recalls 16,672 boxes of Metoprolol Tartrate 50 mg tablets nationwide after nitrosamine exceeds Acceptable Daily Intake. Manufactured by Renata PLC in Bangladesh and distributed in the US by Westminster Pharmaceuticals. Consumers should stop using the product and contact their healthcare provider for guidance.
Hi-Tech Pharmaceuticals recalled 85,950 units of its Quercetin dietary supplement distributed to 40+ states after FDA enforcement found unapproved drug claims and misbranding. The recall, active as of Aug 6, 2025, stems from regulatory concerns rather than a reported health incident. Consumers should stop using the product and contact the company for refunds or replacements.
Hi-Tech Pharmaceuticals recalled 85,950 units of Formutech Nutrition Flexible Joint Formula with Cissus Quadrangularis sold nationwide after regulators flagged unapproved drug claims. The product claims to support tendons and muscles and promote healthy cartilage, which regulators say is not approved. Consumers who purchased the supplement should not use it and should await refund or replacement,'
Hi-Tech Pharmaceuticals recalled 85,950 units of the LG Sciences Battle Hardener Platinum Series Complete 6 Week Cycle dietary supplement due to unapproved drug claims. The recall targets states across the U.S. The company is listed as Hi-Tech Pharmaceuticals. The remedy is a refund or replacement after notification by letter.
Hi-Tech Pharmaceuticals recalled Joint-RX, a 600 mcg dietary supplement sold nationwide, after regulators flagged unapproved drug claims. The recall affects 85,950 units shipped to more than 40 states. Consumers should stop using the product and contact the company for refunds or replacements.
Maquet Cardiovascular recalled 98 Vasoview Hemopro 3 EVH systems nationwide across FL, IL, MD and TX after 16 out-of-box failure complaints. No serious injuries were reported. The failures occurred during limited launch before clinical use.
Hi-Tech Pharmaceuticals recalled 85,950 units of L-Glutamine Ultra Pure Powder distributed to multiple retailers after FDA enforcement over unapproved drug claims. The product’s labeling asserts drug-like benefits without FDA approval. Consumers should not consume the product and should contact Hi-Tech Pharmaceuticals for refund or replacement by mail to 6015-B Unity Drive, Norcross, GA 30071.
Hi-Tech Pharmaceuticals recalled 85,950 units of Slimaglutide weight loss supplement distributed to more than 40 states. The recall cites unapproved drug claims and misbranding. Consumers who purchased Slimaglutide should not use it and should contact Hi-Tech Pharmaceuticals for refund or replacement per the recall notice.