Recalls affecting Puerto Rico
Notices that name Puerto Rico in their distribution area, plus every nationwide recall — nationwide recalls reach Puerto Rico too.
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Class I · 6 months ago
Insulet Corporation Omnipod 5 Pods. Model/ recall: Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod…
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Class II · 6 months ago
ARJOHUNTLEIGH POLSKA Sp. z.o.o. Arjo Tenor mobile passive patient lift recall: An internal component of the actuators in a certain production batch
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst…
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Class II · 6 months ago
3B Medical, Inc. React Health Phoenix 5L Oxygen Concentrator recall: Devices which did not meet internal quality specifications were inadvertently
Devices which did not meet internal quality specifications were inadvertently distributed.
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. QC Quality Choice recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Huons Co., Ltd. Lidocaine HCl Injection, USP, 2%, 100 mg/5mL , 5 mL Single-Dose Vials recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. MGC Health recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Island Kinetics, Inc. d.b.a. CoValence Laboratories Blemish Spot Treatment 1% recall: Failed Stability Specifications
Failed Stability Specifications
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Class II · 6 months ago
Owen Biosciences Inc. HydroPeptide Clear Alliance Serum, 2.5% Benzoyl Peroxide recall: Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. QC Quality Choice recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Huons Co., Ltd. Lidocaine HCl injection, USP, 1% 50mg/5mL , 5 mL Single Dose Vials recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class III · 6 months ago
Avantor Performance Materials LLC Magnesium Chloride, 6-Hydrate, Crystal recall: Subpotent drug
Subpotent drug
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Class II · 6 months ago
Huons Co., Ltd. Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Cipla USA, Inc. Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle recall: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
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Class III · 6 months ago
Island Kinetics, Inc. d.b.a. CoValence Laboratories Skin Rehab recall: Subpotent Drug
Subpotent Drug
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Class II · 6 months ago
Huons Co., Ltd. 0.9% Sodium Chloride Injection, USP, 10 mL Ampules recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. caring mill recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Owen Biosciences Inc. Slmd Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5% recall: Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. QC Quality Choice recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. exchange select recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. QC Quality Choice recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. QC Quality Choice recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
The Harvard Drug Group LLC Memantine Hydrochloride Extended-Release, Capsules recall: Failed Dissolution Specifications
Failed Dissolution Specifications
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. QC Quality Choice recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Sun Pharmaceutical Industries Inc Fluocinonide, USP, 0.05% Cream, 15g tube recall: Failed Viscosity Specifications: Out of Specification results
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.