Recalls and safety warnings for medicines, supplements and medical devices.
The Food and Drug Administration (FDA) is classifying the wearable vibration device for orthopedic use into class II (special controls) effective November 5, 2026. According to the FDA, this classification will provide…
The Food and Drug Administration (FDA) is classifying the prognostic assessment software of mild cognitive impairment into class II (special controls) as of November 5, 2026. According to the FDA, this classification…
On November 5, 2026, the Food and Drug Administration (FDA) announced the classification of the digital cervical cytology slide imaging system with artificial intelligence algorithm into class II (special controls)…
Right Value Drug Stores LLC announced a recall of Testosterone Cypionate, 200 mg/mL, on October 9, 2026. The recall, classified as Class II, affects products packaged in 5 mL and 30 mL vials and is due to a lack of…
The Food and Drug Administration announced a recall of Levoxyl (levothyroxine sodium tablets, USP) distributed by Pfizer Inc. on September 29, 2026. The recall affects tablets in 175 mcg, 100 tablet bottles and…
On October 1, 2026, Shenzhen Techdow Pharmaceutical Co., Ltd. initiated a recall of Heparin Sodium Injection, USP, due to a lack of assurance of sterility. The recall, classified as Class II, may cause temporary or…
PRITAM INTERNATIONAL PRIVATE LIMITED has announced a recall of several toothpaste products due to cGMP deviations. The recall, classified as Class II, may cause temporary or reversible health problems and began on…
On October 1, 2026, Greenwich Rx initiated a Class I recall of its Glutathione Injection, which is classified as the most serious type of recall. The recall affects the 200 mg/mL, 10 mL multi-dose vial, which is…
Par Health USA, LLC announced a Class I recall of Argatroban Injection, USP, 250 mg/2.5mL, on October 13, 2026. The recall affects products distributed nationwide and is ongoing due to the presence of particulate…
On September 24, 2026, Philips Ultrasound, LLC initiated a Class I recall for its Lumify Diagnostic Ultrasound System. The recall affects devices distributed worldwide, including across the United States and numerous…
On September 17, 2026, Ventec Life Systems, Inc. initiated a Class I recall of several ventilatory support devices due to a potential safety issue. The recall affects devices including the VOCSN and V+ Pro Emergency…
On November 2, 2026, the Food and Drug Administration proposed to amend regulations on nutrient specifications and labeling for infant formula. The proposed rule includes changes to the minimum and/or maximum levels of…
The Food and Drug Administration (FDA) is classifying the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer into class II (special controls) effective October 30…
On October 30, 2026, the Food and Drug Administration (FDA) announced the classification of radiology software for referral of findings related to fibrotic lung disease into class II (special controls). This…
On October 30, 2026, the Food and Drug Administration (FDA) issued a final order classifying the spinal imaging system for neuraxial procedures into class II (special controls). The FDA determined that this…
The Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of sleep apnea into class II (special controls) effective October 30, 2026. According to the FDA, this classification…
American Health Packaging is recalling Metoclopramide Tablets, USP, 5 mg, due to the presence of foreign tablets or capsules. The recall, classified as Class II, began on October 6, 2026, and is ongoing, affecting…
On September 29, 2026, Teva Pharmaceuticals USA, Inc initiated a recall of Metoclopramide Tablets, USP, 5 mg, due to the presence of foreign tablets or capsules. The recall, classified as Class II, may cause temporary…
On October 21, 2026, the Food and Drug Administration announced a Class I recall of medical devices from Instrumentation Laboratory. The recall, which began on September 3, 2026, affects the HemoslL AcuStar…
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