689 recalls tagged with “fda regulated”.
Enterix recalled 201,426 InSure ONE fecal immunochemical test kits on September 17, 2025. The kits may produce false negative results due to failed sensitivity testing with Test Card Lot T241102. The recall affects units distributed worldwide, including multiple states in the U.S.
D & M Smoked Fish, Inc. recalled 2,022 pieces of Haifa Cold Smoked Salmon on September 17, 2025. The product is contaminated with Listeria monocytogenes, which poses a serious health risk. Consumers in NY, NJ, PA, WA, CA, IL, and FL should not consume this product.
IntegraDose Compounding Services LLC recalled 853 bags of Oxytocin 30 Units/500 mL on September 16, 2025. Testing revealed these IV bags contain no oxytocin, posing serious health risks. The recall affects products distributed nationwide in the USA.
Accord Healthcare recalled 54,432 bottles of Levothyroxine Sodium Tablets on September 16, 2025. The tablets were found to be subpotent during stability testing. Consumers should stop using the product immediately and seek guidance from healthcare providers.
Lawrence Wholesale recalled 4,871 cases of frozen cooked shrimp on September 16, 2025. The product may have been contaminated with Cesium-137. Consumers should not consume the shrimp and seek refunds.
Graviti Pharmaceuticals recalled 46,512 bottles of Bupropion Hydrochloride Extended-Release Tablets on September 15, 2025. The recall stems from failed tablet specifications that could affect safety and efficacy. The product was distributed to pharmacies nationwide.
Private Label Skin Care recalled Benzaderm BPO Cleanser 10% on September 12, 2025. Elevated benzene levels prompted the recall affecting consumers in California and Georgia. No injuries have been reported.
Private Label Skin Care recalled its Micronized BPO Gel Cleanser 10% on September 12, 2025. Elevated benzene levels prompted the recall in California and Georgia. Consumers must stop using the product immediately and seek guidance from healthcare providers.
Skin MD by Dr Monika Kiripolsky recalled its Body Acne Cleanser on September 12, 2025. The recall follows the discovery of elevated benzene levels in the product. This contamination poses a high health risk to consumers in California and Georgia.
Private Label Skin Care recalled its edunn clarity BP Treatment Cleanser on September 12, 2025. Elevated benzene levels prompted the recall after post-consumer awareness. The product was distributed in California and Georgia.
Major Pharmaceuticals recalled 2,064 blister packs of Chlorpromazine Hydrochloride Tablets on September 12, 2025. The recall follows the discovery of N-Nitroso Desmethyl Chlorpromazine exceeding safe limits. Consumers must stop using this product immediately and consult healthcare providers for guidance.
Rising Pharma Holdings recalled 13,440 bottles of Cetirizine Hydrochloride Tablets on September 12, 2025. The tablets are imprinted with incorrect identification. This recall affects consumers nationwide.
GE HealthCare recalled 82 units of the Millenium Myosight gamma camera on September 12, 2025. The recall affects systems that may lack sufficient support during transport, posing a risk of detector falls. This defect can result in life-threatening injuries.
Ben's Original Ready Rice Whole Grain Brown has been recalled due to potential contamination with stones. The recall affects 315 cases sold in several states including Wisconsin and Texas. Consumers should not consume the product and seek refunds immediately.
UIH Technologies recalled 8 units of its uCT 530 MD X-ray system on September 12, 2025. Third-party outer covers can trap between the patient table and gantry, causing mechanical interference. Healthcare providers and patients must stop using the device immediately.
Shanghai United Imaging Healthcare Co., Ltd. recalled 11 units of its uCT 760 MD Computed Tomography X-ray System on September 12, 2025. The recall addresses a serious hazard where third-party outer covers can become trapped between the patient table and gantry, leading to mechanical interference. Healthcare providers and patients must stop using the device immediately and follow recall directives
Major Pharmaceuticals recalled 1,394 blister packs of Chlorpromazine Hydrochloride Tablets due to contamination concerns. The recall occurred on September 12, 2025, after the FDA found N-Nitroso Desmethyl Chlorpromazine above acceptable limits. Consumers should stop using these tablets and seek guidance from healthcare providers.
Boston Scientific recalled 59 units of the TENACIO Pump with InhibiZone on September 11, 2025. The recall addresses potential inflation and deflation performance issues. Patients should stop using the device immediately and follow the manufacturer's instructions.
Medline Industries recalled 8,267,150 saline flush syringes on September 11, 2025. The syringes may not meet the required concentration of sodium chloride. Consumers and healthcare providers must stop using these products immediately.
Olympus Corporation of the Americas recalled 395 units of the EVIS EXERA II Bronchovideoscope BF Type Q180-AC on September 11, 2025. The recall addresses additional instructions for safe use with laser and high-frequency therapy equipment. Healthcare providers must stop using the device immediately.