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Medical Device
FDA Devices
FDA DevicesCytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Integra LifeSciences Corp. (NeuroSciences)
FDA DevicesClass II
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Increased rate of out-of-specification endotoxin results.
Apr 22, 2026Integra LifeSciences Corp. (NeuroSciences)
PharmaceuticalFDA Drugs
FDA DrugsEPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
International Medication Systems Ltd.
FDA DrugsClass II
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
Lack of Assurance of Sterility
Apr 22, 2026International Medication Systems Ltd.
PharmaceuticalFDA Drugs
FDA Drugscaring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
FDA DrugsClass II
caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Apr 22, 2026Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Medical DeviceFDA Devices
FDA DevicesB. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
B Braun Medical Inc
FDA DevicesClass I
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Apr 22, 2026B Braun Medical Inc
PharmaceuticalFDA Drugs
FDA DrugsCinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Cipla USA, Inc.
FDA DrugsClass II
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Apr 22, 2026Cipla USA, Inc.
Pharmaceutical
UK
UKClass 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20
Doncaster Pharma Limited
uk-mhraMedicines Recall
Class 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20
Doncaster Pharma Limited has informed the MHRA of an error related to the Braille embossing on the outer packaging of certain parallel imported batches of Hiprex 1 g tablets (POM)....
Apr 22, 2026Doncaster Pharma Limited
Medical DeviceFDA Devices
FDA DevicesCytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Integra LifeSciences Corp. (NeuroSciences)
FDA DevicesClass II
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
Increased rate of out-of-specification endotoxin results.
Apr 22, 2026Integra LifeSciences Corp. (NeuroSciences)
Food & Beverage
Germany BVL
Germany BVLCrab Blue Swimming Cut U/10 Casabor
Star Impex e.K, Franziusstrasse 150, 44147 Dortmund
Germany BVLGeneral Alert
Crab Blue Swimming Cut U/10 Casabor
Rückstände und Kontaminanten
Apr 22, 2026Star Impex e.K, Franziusstrasse 150, 44147 Dortmund
RappelConsovolontaire (san...
casabor - crabe bleu surgelé coupé u/10 1 kilo
contaminant - polluant organique persistant > substances perfluoroalkylées (pfas) ¤précision du danger pfoa
Apr 22, 2026casabor
PharmaceuticalFDA Drugs
FDA DrugsCinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
Cipla USA, Inc.
FDA DrugsClass II
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Apr 22, 2026Cipla USA, Inc.
Medical DeviceFDA Devices
FDA DevicesReact Health PHOENIX 5L Oxygen Concentrator
3B Medical, Inc.
FDA DevicesClass II
React Health PHOENIX 5L Oxygen Concentrator
Devices which did not meet internal quality specifications were inadvertently distributed.
Apr 22, 20263B Medical, Inc.
PharmaceuticalFDA Drugs
FDA DrugsFHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas
Owen Biosciences Inc.
FDA DrugsClass II
FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas
Chemical contamination: Presence of benzene
Apr 22, 2026Owen Biosciences Inc.
Medical DeviceFDA Devices
FDA DevicesInstinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Wilson-Cook Medical Inc.
FDA DevicesClass II
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Apr 22, 2026Wilson-Cook Medical Inc.
PharmaceuticalFDA Drugs
FDA DrugsFluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1
SUN PHARMACEUTICAL INDUSTRIES INC
FDA DrugsClass II
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Apr 22, 2026SUN PHARMACEUTICAL INDUSTRIES INC
PharmaceuticalFDA Drugs
FDA DrugsBlemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Island Kinetics, Inc. d.b.a. CoValence Laboratories
FDA DrugsClass II
Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Failed Stability Specifications
Apr 22, 2026Island Kinetics, Inc. d.b.a. CoValence Laboratories
Medical DeviceFDA Devices
FDA DevicesPhilips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA DevicesClass II
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
Apr 22, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
PharmaceuticalFDA Drugs
FDA DrugsLidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)
Huons Co., Ltd.
FDA DrugsClass II
Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)
Lack of Assurance of Sterility
Apr 22, 2026Huons Co., Ltd.
Food & BeverageFDA Food
FDA FoodRaw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00001 8 100% Pure Honey Bee Well Honey 909 W. Main Street Pickens, SC 29671
Bee Well Honey Farm & Supply Inc.
FDA FoodClass III
Raw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00001 8 100% Pure Honey Bee Well Honey 909 W. Main Street Pickens, SC 29671
High sugar content. The firm was notified by the FDA that sample results were positive for a high C4 sugar content.
Apr 22, 2026Bee Well Honey Farm & Supply Inc.
PharmaceuticalFDA Drugs
FDA DrugsBupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)
Huons Co., Ltd.
FDA DrugsClass II
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)
Lack of Assurance of Sterility
Apr 22, 2026Huons Co., Ltd.
PharmaceuticalFDA Drugs
FDA DrugsSLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.
Owen Biosciences Inc.
FDA DrugsClass II
SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.
Chemical contamination: Presence of benzene
Apr 22, 2026Owen Biosciences Inc.
Medical DeviceFDA Devices
FDA DevicesCytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Integra LifeSciences Corp. (NeuroSciences)
FDA DevicesClass II
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Increased rate of out-of-specification endotoxin results.
Apr 22, 2026Integra LifeSciences Corp. (NeuroSciences)
PharmaceuticalFDA Drugs
FDA DrugsDesmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0
Apotex Corp.
FDA DrugsClass II
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Apr 22, 2026Apotex Corp.
PharmaceuticalFDA Drugs
FDA DrugsSLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.
Owen Biosciences Inc.
FDA DrugsClass II
SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.
Chemical contamination: Presence of benzene
Apr 22, 2026Owen Biosciences Inc.
PharmaceuticalFDA Drugs
FDA DrugsSemaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR
PAYLESS COMPOUNDERS, LLC
FDA DrugsClass II
Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR
Lack of Assurance of Sterility
Apr 22, 2026PAYLESS COMPOUNDERS, LLC