fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DRUG

Endo USA Recalls 1,041 Cartons of Everolimus 5mg Tablets Over IP-C Impurity (2025)

Endo USA, Inc. recalled 1,041 cartons of Everolimus 5mg tablets nationwide in the United States due to an impurity IP-C out of specification. The impurity IP-C is out of specification in the drug product. Patients and healthcare providers should stop using this product immediately and contact Endo USA or their healthcare provider for guidance.

Everolimus
Failed Impurities/Degradation
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Food & Beverages
HIGH
FDA FOOD

Chetak New York Recalls Frozen Guvar Due to Salmonella Risk

Chetak New York LLC recalled over 3.5 million bags of frozen Guvar on September 5, 2025, after testing positive for Salmonella. The recall affects products sold in the United States. Consumers should not consume the recalled product and seek a refund or replacement immediately.

CHETAK NEW YORK
Product tested
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ultrasound L17-5 Transducer Recalled for Useful-Life Labeling (2025)

Two Philips Ultrasound L17-5 transducers distributed nationwide to hospitals are recalled. The recall targets labeling that defines the devices' useful life. Stop using the transducers and follow Philips Ultrasound's instructions. Hospitals should contact Philips Ultrasound for guidance.

Philips Ultrasound
To provide
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Food & Beverages
HIGH
FDA FOOD

CHETAK NEW YORK Recalls Frozen Suran Over Salmonella Risk

CHETAK NEW YORK recalled 3,509,532 bags of its Premium Select Suran on September 5, 2025. The product tested positive for Salmonella, posing a serious health risk to consumers. Customers should stop using the product immediately and seek a refund or replacement.

CHETAK NEW YORK
Product tested
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Food & Beverages
HIGH
FDA FOOD

Chetak New York Recalls Hot Green Chillies Over Salmonella Risk

Chetak New York recalled over 3.5 million bags of PREMIUM Select Hot Green Chillies on September 5, 2025. The product tested positive for Salmonella, a bacteria that can cause serious illness. Consumers should not eat the product and should seek a refund or replacement immediately.

CHETAK NEW YORK
Product tested
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Food & Beverages
HIGH
FDA FOOD

Chetak New York Recalls Frozen Tindora Over Salmonella Risk

Chetak New York recalled over 3.5 million bags of frozen Tindora on September 5, 2025. The recall follows positive tests for Salmonella, a bacteria that can cause serious illness. Consumers should not consume the product and seek a refund or replacement immediately.

CHETAK NEW YORK
Product tested
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Food & Beverages
HIGH
FDA FOOD

Chetak New York Recalls Frozen Tuvar Lilva Due to Salmonella

Chetak New York recalled over 3.5 million bags of frozen Tuvar Lilva on September 5, 2025. The product tested positive for Salmonella, posing a significant health risk. Consumers should not consume this product and seek a refund or replacement immediately.

CHETAK NEW YORK
Product tested
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ultrasound S5-2 Transducer Recall 2025 - 1 Unit Nationwide

Philips Ultrasound recalled 1 unit of the S5-2 Ultrasound Transducer sold nationwide through healthcare distributors. The recall clarifies labeling to define the useful life of the transducer in the field. Healthcare providers should stop using the device and contact Philips Ultrasound for instructions.

Philips Ultrasound
To provide
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Health & Personal Care
LOW
FDA DEVICE

Philips S4-1 Ultrasound Transducer Recall: 41 Units Nationwide in 2025

Philips Ultrasound, Inc. recalled 41 S4-1 Ultrasound Transducers distributed nationwide in the United States. The recall is to provide clarification and labeling to define the useful life of ultrasound transducers in the field. Healthcare providers should stop using these devices immediately and follow the recall instructions from Philips or their facility.

Philips Ultrasound
To provide
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Health & Personal Care
HIGH
FDA DRUG

Apotex Ketorolac Tromethamine Ophthalmic Solution Recall 2025: 493,468 Bottles Nationwide

Apotex Corp. is recalling 493,468 bottles of Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Rx Only, sterile, distributed nationwide in the United States. The recall cites lack of assurance of sterility due to improper bottle sealing. Consumers and healthcare providers should stop using the product immediately and contact Apotex Corp. or their healthcare provider for guidance.

Apotex
Lack of
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Health & Personal Care
HIGH
FDA DEVICE

Philips Ultrasound OMNI II TEE Transducer Recall Two Units Nationwide (2025)

Philips Ultrasound recalled 2 units of the Philips OMNI II TEE Ultrasound Transducer sold nationwide through multiple retailers. The recall seeks labeling clarification to define the transducer's useful life. Healthcare facilities should stop using the devices and follow Philips recall instructions.

Philips Ultrasound
To provide
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls 32,433 Cardiac Cath Lab Kits Due to Re-Gassed Sterilization Risk (

American Contract Systems recalled 32,433 cardiac cath lab kits distributed nationwide to healthcare providers. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process. The kits have not been validated for exposure to multiple sterilization cycles and cannot be guaranteed safe.

American Contract Systems
Identified products
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems High-Rire Recall: 32,433 Medical Convenience Kits Recalled for Re-GassedEO

American Contract Systems recalled 32,433 medical convenience kits nationwide after finding re-gassed devices from EO sterilization. The recall affects five product lines with UDI-DI codes and Lot numbers. The re-gassing process has not been validated for multiple sterilization cycles, calling into question product safety and effectiveness. Health providers and patients should stop using these kit

American Contract Systems
Identified products
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems High-Index Medical Kits Recalled for Re-Gassing After EO Sterilization Non

American Contract Systems recalled 32,433 medical convenience kits nationwide in the United States after re-gassing sterilization cycles. The recall covers multiple packs including HEART PACK and PACEMAKER PACK with 2025 recall date. The safety issue centers on EO gasset validation failures after a nonconformance during initial gas injection. Stop using immediately and follow recall instructions.

American Contract Systems
Identified products
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Food & Beverages
HIGH
FDA FOOD

Pacific Coast Producers Fruit Cocktail Recalled for Lead Contamination in 15 oz Cans (609 cases)

Pacific Coast Producers recalled 609 cases of Fruit Cocktail in 15 oz cans distributed by Wegmans Food Markets over lead contamination concerns. The recall cites potential contamination with lead. Consumers who purchased the product should not consume it and should contact Pacific Coast Producers for a refund or replacement.

Pacific Coast Producers
Potential contamination
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalling 32,433 UDPG88W PICC G-TUBE Pack in 2025 Recall

American Contract Systems recalled 32,433 UDPG88W PICC G-TUBE PACK medical kits nationwide after a nonconformance in Ethylene Oxide sterilization led to re-gassing. The devices have not been validated for multiple sterilization cycles. Healthcare providers and patients should stop using the kit immediately and follow recall instructions.

American Contract Systems
Identified products
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Basic Biopsy Tray Recalled for Re-Gassing Hazard (32,433 Units) 2025Recall

American Contract Systems recalled 32,433 Basic Biopsy Trays nationwide after discovering re-gassing occurred following a nonconformance during Ethylene Oxide sterilization. The trays have not been validated for exposure to multiple sterilization cycles, so product quality and safety cannot be confirmed. Healthcare providers and patients should stop using the device immediately and follow theメーカー?

American Contract Systems
Identified products
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Food & Beverages
HIGH
FDA FOOD

Pacific Coast Producers Halved Pears in Pear Juice Recall 2025 — 102 Cases Lead Contamination

Pacific Coast Producers recalled 102 cases of Halved Pears in Pear Juice Concentrate sold nationwide through Wegmans distribution after detecting potential lead contamination. The product is packaged in 15-ounce cans with Lot 6PJ 09 C2295 and UPC 077890747490. Consumers should stop using the product and contact Pacific Coast Producers for refund or replacement.

Pacific Coast Producers
Potential contamination
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Tag Statistics

Total Recalls
1,264

Related Tags

chemical hazardpoisoning riskadult productimmediate actionstop use immediatelyreturn for refundreplacement availablebattery poweredelectrical hazardcpsc regulatedoutdoorinfant product
    fda regulated Recalls | RecallRadar