fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DRUG

Zydus Lifesciences Chlorpromazine Tablets Recalled for N-Nitroso Desmethyl Chlorpromazine Beyond FDA

Chlorpromazine Hydrochloride Tablets, 200 mg, 100-count bottle, manufactured by Zydus Lifesciences Ltd. and distributed by Northstar Rx LLC, are under recall nationwide in the United States. The CGMP deviation involves elevated levels of N-Nitroso Desmethyl Chlorpromazine. Consumers should stop use and contact their healthcare provider.

Zydus Lifesciences
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Nederland B.V. Allura CV20 Recalled in Global Distribution for Component D-7

Philips Medical Systems Nederland B.V. recall involves 46 Allura CV20 imaging systems distributed worldwide. The devices may fail to perform due to deterioration of internal components including the CMOS battery, hard disk drive and power supply unit. If this occurs, motorized movements could become unavailable while imaging remains functional. The recall alerts patients and healthcare providers;停

Philips Medical Systems Nederland B.V.
Systems may
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Nederland B.V. Recalled 98 Imaging Systems for CMOS Battery, HDD, PSU Deteri

Philips Medical Systems Nederland B.V. recalls 98 imaging systems worldwide after reports of component deterioration. Systems may lose motorized movements due to CMOS battery, hard disk drive, or power supply deterioration. Imaging remains available. Stop using the device and follow manufacturer instructions.

Philips Medical Systems Nederland B.V.
Systems may
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Food & Beverages
HIGH
FDA FOOD

Endico Potatoes Frozen Mixed Vegetables Recalled Over Listeria Risk in 2025 (280 cases)

Endico Potatoes Inc recalled 280 cases of Endico brand Frozen Mixed Vegetables distributed to retailers in New York, New Jersey, Connecticut, Florida, Pennsylvania, Maryland and the District of Columbia. The product may be contaminated with Listeria monocytogenes. Consumers should not eat the product and should contact Endico Potatoes for refunds or replacements.

Endico Potatoes
Product may
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Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD10 OR Table Recall for 2 Units Worldwide in 2025

Philips Medical Systems Nederland B.V. recalls 2 Allura Xper FD10 OR Tables worldwide. The devices may fail to perform motorized movements due to deterioration of internal components. Healthcare providers should stop using the devices and contact Philips for instructions.

Philips Medical Systems Nederland B.V.
Systems may
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Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD20/20 Recall Affects 75 Systems Worldwide for Internal Component Deterioration

Philips Medical Systems Nederland B.V. recalls 75 Allura Xper FD20/20 imaging systems due to potential deterioration of the CMOS battery, hard drive and power supply. Motorized movements could become unavailable while X-ray imaging remains functional. Operators should stop using affected units and follow manufacturer instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Systems may
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Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD20 Recall Affects 2,114 Units Globally Over Power Component Deterioration

Philips Medical Systems Nederland B.V. recalls 2,114 Allura Xper FD20 imaging systems sold worldwide after reports that internal components may deteriorate. The recall covers models 722012, 722028 and 722006 with associated 510(k) numbers K102005 and K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949. If deterioration occurs, motorized movements may fail. Manual and imaging功能s,

Philips Medical Systems
Systems may
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Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD10/10 Recall for 286 Units Worldwide in 2025

Philips Medical Systems Nederland B.V. recalled 286 Allura Xper FD10/10 fluoroscopy systems worldwide, including 67 US units. Deterioration of internal components such as the CMOS battery, hard disk drive, and power supply can disable motorized system movements. Hospitals and other healthcare providers should stop using affected devices and follow the manufacturer’s recall instructions.

Philips Medical Systems Nederland B.V.
Systems may
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Health & Personal Care
HIGH
FDA DRUG

Viorele Desogestrel/Ethinyl Estradiol Recall 2025 for Impurities

Viorele birth-control pills are recalled in the United States for failed impurity and degradation specifications. Glenmark Pharmaceuticals Inc. is distributing the issue nationwide, affecting 26,928 packs. Patients should stop using the product and contact a clinician for guidance.

Viorele
Failed Impurities/Degradation
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Nederland Faces High-Risk Recall for Allura Xper FD20/15 BIOS Battery

Philips Medical Systems Nederland B.V. recalls 300 units of the Allura Xper FD20/15 with model 722058 after the BIOS battery may deplete prematurely, causing startup failure. The recall covers worldwide distribution. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS
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Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD20 Biplane Recalled for BIOS Battery Failure in 501 Units (2025)

Philips Medical Systems Nederland recalled 501 Allura Xper FD20 Biplane devices sold worldwide to hospitals and healthcare facilities. The BIOS battery may deplete faster during design, halting the startup and preventing the system from starting with no user messages. Healthcare providers and patients should stop using the device and follow the recall instructions from Philips.

Philips Medical Systems Nederland
The BIOS
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Health & Personal Care
HIGH
FDA DEVICE

Beckman Coulter Phosphorus Reagent Recall: 2,146 Units for Calibration Failures

Beckman Coulter recalled 2,146 units of the SYNCHRON Systems Phosphorus (PHOSm) Reagent due to calibration failures that may delay patient results. Specific reagent lots may not function properly before their expiration date. Healthcare providers and patients must stop using these reagents immediately and follow manufacturer instructions.

Beckman Coulter
Specific SYNCHRON
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Health & Personal Care
HIGH
FDA DEVICE

PHILIPS Allura Xper FD10/10 Recall Tied to BIOS Battery Depletion

Philips Medical Systems Nederland B.V. recalled 585 units of the Allura Xper FD10/10 diagnostic system globally, including 145 in the United States, after reports that the BIOS battery can deplete faster than expected and halt system startup. The recall covers models 722005, 722011, and 722027. Healthcare facilities should stop using the device and follow manufacturer instructions for remediation.

Philips Medical Systems Nederland B.V.
The BIOS
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Food & Beverages
HIGH
FDA FOOD

New Spirit Naturals Ultra Whey Protein Powder Recalled for Undeclared Milk Allergen

New Spirit Naturals recalled 37 units of Ultra Whey Protein Powder sold directly through its online store after undeclared milk allergen was detected. The recall is currently active with a high-hazard designation. Consumers who have purchased the product should not consume it and should contact the company for refunds or replacements.

New Spirit Naturals
undeclared allergen
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