fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

Food & Beverages
HIGH
FDA FOOD

Organicare Nature's Science FemiClear Daily Bladder Strength Recall 15,075 Bottles in 2025 Over E. C

Organicare Nature's Science recalled 15,075 bottles of FemiClear Daily Bladder Strength, sold in retail stores across all 50 states and Puerto Rico and online. The recall cites microbial contamination with Escherichia coli O7:K1 and E. coli 1303. Consumers should stop using the product and contact Organicare Nature's Science for a refund or replacement.

Organicare Nature's Science
Microbial contamination
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls 32,433 Medical Convenience Kits Over Re-Gassing Risk (2025)

American Contract Systems recalled 32,433 medical convenience kits sold through multiple retailers nationwide. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process and have not been validated for exposure to multiple sterilization cycles. Healthcare providers and patients should stop using these products immediately and follow the manufacturer's recall.

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

American Contract Systems Recalled 32,433 Orthopedic Surgical Kits Over Re-Gassing Risk (2025)

American Contract Systems recalled 32,433 medical convenience kits sold through multiple retailers nationwide in SD, IA, MN, WA and IL. The devices were re-gassed after a nonconformance in the Ethylene Oxide sterilization process. The sterilization cycles have not been validated, so quality, safety and effectiveness cannot be confirmed. Consumers and healthcare providers should stop using the kits

American Contract Systems
Identified products
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Food & Beverages
HIGH
FDA FOOD

ONE FROZEN Recalls Good and Gather Southwest-Style Burrito Bowl Blend for Shrimp Allergen (2025)

ONE FROZEN recalled 57,240 bags of Good and Gather Southwest-Style Burrito Bowl Blend sold nationwide after discovering undeclared shrimp. The product may contain shellfish due to cross-contact risk in a facility that also handles shellfish and other allergens. Consumers should not eat the product and should contact ONE FROZEN for a refund or replacement.

ONE FROZEN
Product may
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls 32,433 Basic Biopsy Trays Re-Gassed After EO Sterilization (2025)

American Contract Systems recalled 32,433 basic biopsy trays distributed nationwide in the United States. These trays were re-gassed after a nonconformance occurred during the initial Ethylene Oxide gas injection. The trays have not been validated for exposure to multiple sterilization cycles. Healthcare providers and patients should stop using affected trays and follow recall instructions.

American Contract Systems
Identified products
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Food & Beverages
HIGH
FDA FOOD

Gospodarstwo Pasieczne Sadecki Bartnik Bee Pollen 200g Recall for Pyrrolizidine Alkaloids (2025)

Gospodarstwo Pasieczne Sadecki Bartnik recalled 336 jars of Bee Pollen sold in Illinois after tests detected pyrrolizidine alkaloids. The product contains detectable pyrrolizidine alkaloids. Consumers should not consume the product and should contact the producer by telephone for refund or replacement.

Gospodarstwo Pasieczne Sadecki Bartnik
detectable pyrrolizidine
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls 32,433 Angio Packs Over Re-Gassed EO Sterilization (2025)

American Contract Systems is recalling 32,433 medical Angio Packs distributed nationwide in the United States. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process. Healthcare facilities and patients should stop using the devices and follow the manufacturer’s recall instructions.

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

Lutronic XERF EFFECTOR 60 Electrosurgical Unit Recalled for Manufacturing Defects (2025-2026 Models)

Lutronic recalled 7,490 XERF EFFECTOR 60 electrosurgical units distributed worldwide, including several U.S. states, after manufacturing defects surfaced between April 1 and August 20, 2025. The defect can cause adverse events for patients. Healthcare providers and patients should stop using the device immediately and follow the manufacturer’s recall instructions.

Lutronic
Manufacturing defects
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls 32,433 Medical Convenience Kits Over EO Re-Gassing Risk (2025)

American Contract Systems Inc. recalls 32,433 medical convenience kits distributed nationwide to healthcare facilities in SD, IA, MN, WA, and IL. Re-gassed after a nonconformance occurred during Ethylene Oxide gas injection. The kits have not been validated for multiple sterilization cycles. Healthcare providers should stop using the devices immediately and follow recall instructions.

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

Philips Allura Xper FD20 Biplane Recall Affects 268 Units Worldwide (2025)

Philips Medical Systems Nederland B.V. recalled 268 Allura Xper FD20 Biplane imaging systems worldwide, including 102 in the United States. The recall cites deterioration of internal components that could disable motorized movements. Hospitals should stop using the devices immediately and follow the manufacturer’s recall instructions.

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

Zydus Chlorpromazine Hydrochloride 10 mg Tablets Recalled for Nitrosamine Impurity (2025)

Zydus Lifesciences and Zydus Pharmaceuticals US recall Chlorpromazine Hydrochloride Tablets, 10 mg, 100-count bottles sold nationwide in the United States after detecting an impurity above acceptable intake. The impurity is N-Nitroso Desmethyl Chlorpromazine. Consumers should stop using the product immediately and contact the manufacturer for guidance.

Chlorpromazine Hydrochloride
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD20/10 Recall 45 Units Worldwide in 2025

Philips Medical Systems Nederland B.V. recalls 45 Allura Xper FD20/10 imaging systems worldwide due to internal component deterioration. The CMOS battery, hard disk drive and/or power supply may fail. Motorized movements can become unavailable while imaging remains possible. Stop using the device and follow manufacturer instructions.

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

Zydus Lifesciences Chlorpromazine Hydrochloride 100 mg Recall 2025

Zydus Lifesciences Chlorpromazine Hydrochloride Tablets, 100 mg, 100-count bottles distributed nationwide in the USA for Northstar Rx LLC, Memphis, TN 38141, are recalled. The recall cites CGMP deviations with the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake. Healthcare providers and patients should stop using the product immediately and contact the manufacturer or a医

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

Zydus Lifesciences Chlorpromazine Hydrochloride Tablets 25 mg 100-count Recall 2025

Zydus Lifesciences and Northstar Rx LLC recall Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottles nationwide in the United States. The recall cites CGMP deviations and the presence of N-nitroso desmethyl chlorpromazine above acceptable intake limits. Consumers should stop using the product and contact the manufacturer or a healthcare provider for guidance.

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

Zydus Lifesciences Chlorpromazine Hydrochloride Tablets 50 mg 100-count Recall 2025

Zydus Lifesciences and Northstar Rx LLC recall Chlorpromazine Hydrochloride Tablets, 50 mg, 100-count bottles distributed nationwide in the United States. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. Stop using the product immediately and contact your healthcare provider or Zydus Pharmaceuticals (USA) Inc for guidance.

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

Zydus Lifesciences Chlorpromazine Hydrochloride Tablets Recall 100-Count Bottles (2025)

Zydus Lifesciences Ltd. recalled chlorpromazine hydrochloride tablets nationwide in the United States after tests found N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. The issue involves CGMP deviations in manufacturing at the India facility and distribution by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ. Healthcare providers and patients should stop using the product, 0

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

Sun Pharmaceutical Radiopharmaceutical Kit Recall: 1,870 Kits Recalled for OOS Dissolution Issue

Sun Pharmaceutical Industries recalled 1,870 kits nationwide after an out-of-specification dissolution test for sulphate in Sodium Tartrate Dihydrate used to produce Mertiatide. The recall affects Rx-only kits distributed across the U.S. Healthcare providers and patients should stop using the product immediately and follow guidance from Sun Pharmaceutical. Contact information is provided by the UQ

Sun Pharmaceutical Industries
Failed Dissolution
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Health & Personal Care
HIGH
FDA DRUG

Zydus Lifesciences Chlorpromazine Hydrochloride 25 mg 100-count Tablets Recalled Nationwide (2025)

Zydus Lifesciences Ltd. recalled Chlorpromazine Hydrochloride tablets, 25 mg, 100-count bottles distributed nationwide by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. Stop using the product and contact your healthcare provider or Zydus Pharmaceuticals (USA) Inc. for

Chlorpromazine Hydrochloride
CGMP Deviations:
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Health & Personal Care
HIGH
FDA DRUG

Zydus Lifesciences Chlorpromazine Hydrochloride 100 mg Recall 2025

Zydus Lifesciences Ltd. and Zydus Pharmaceuticals (USA) Inc. recall Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottles distributed nationwide in the United States. The recall stems from CGMP deviations that allowed N-Nitroso Desmethyl Chlorpromazine to exceed the acceptable intake limit. Health care providers and patients should stop using the product and contact the manufacturer

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

Zydus Chlorpromazine Hydrochloride 200 mg Recall Expands Nationwide Over CGMP Deviations

The FDA confirms a nationwide recall of Zydus Lifesciences Chlorpromazine Hydrochloride tablets 200 mg (NDC 70710-1133-1) distributed by Zydus Pharmaceuticals USA. The recall cites CGMP deviations and the presence of N-Nitroso Desmethyl Chlorpromazine above acceptable intake. Consumers and healthcare providers should stop using the product immediately and contact the distributor for guidance.

Chlorpromazine Hydrochloride
CGMP Deviations:
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Tag Statistics

Total Recalls
1,264

Related Tags

adult productstop use immediatelyreturn for refundreplacement availablecpsc regulatedimmediate actionchemical hazardelectrical hazardsuffocation riskinfant productmandatory standard violationrepair available