Estados Unidos Recalls

Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.

AvKARE

MIN JIANG FOOD STORE INC DBA KOI KOI TRADING

Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.

Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.

Mar 4, 2026AvKARE

Food & Beverage

FDA Food

Fish Ball, Frozen, 20 pieces per pack, 400g Wt. UPC# 810093891325

FDA FoodClass I

Fish Ball, Frozen, 20 pieces per pack, 400g Wt. UPC# 810093891325

Undeclared allergen ingredient (Wheat and Sesame)

Mar 4, 2026MIN JIANG FOOD STORE INC DBA KOI KOI TRADING

Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.

Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Volkswagen Group of America, Inc.

Vehicle Recall

NHTSA

Volkswagen Group of America, Inc. - Lane Departure Warning Deactivated

NHTSALANE DEPARTURE

Volkswagen Group of America, Inc. - Lane Departure Warning Deactivated

The driver may be unaware that the lane departure warning system is deactivated and rely on a system that is not functional, increasing the risk of a crash.

Mar 4, 2026Volkswagen Group of America, Inc.

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR

Mar 4, 2026Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR

Software anomaly in the patient positioning system may result in positional discrepancy.

Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,

LEO PHARMA INC

Mar 4, 2026LEO PHARMA INC

Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,

Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.

Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.

Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214

Medline Industries, LP

Mar 4, 2026Medline Industries, LP

Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

Food & Beverage

FDA Food

YO!MAN LETTUCE (SPICY FLAVOR); Ingredients: Lettuce, chili pepper, edible vegetable oil, salt, water, sugar, food additives (monosodium glutamate, potassium sorbate, streptoccoccus lactis, sodium dehydroacetate, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, sucralose, xanthan gum, disodium 5'flavoring ribonucleotide), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 9 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529626

TENGEN USA TRADING CORP

FDA FoodClass III

YO!MAN LETTUCE (SPICY FLAVOR); Ingredients: Lettuce, chili pepper, edible vegetable oil, salt, water, sugar, food additives (monosodium glutamate, potassium sorbate, streptoccoccus lactis, sodium dehydroacetate, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, sucralose, xanthan gum, disodium 5'flavoring ribonucleotide), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 9 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529626

Product contains undeclared cyclamates.

Mar 4, 2026TENGEN USA TRADING CORP

Slate Run Pharmaceuticals

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80

FDA DrugsClass III

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80

Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.

Mar 4, 2026Slate Run Pharmaceuticals

PIE Trolley System Model: 2005

Edermy LLC

Mar 4, 2026J2C Hawaii LLC

PIE Trolley System Model: 2005

Lack of 510K clearance

Mar 4, 2026Edermy LLC

Food & Beverage

FDA Food

Tiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel. Net wt: Approx: 2 oz (57g). UPC 8 55725 00514 0. Taste of Maui Snacks dba of J2C Hawaii, LLC PO Box 1023, Wailuku HI 96793. The product label is read in parts: INGREDIENTS: SugarWhey Powder, Nonfat Milk Powder, Soy LecithinPeanut Butter (peanuts, peanut oil), Pretzels (wheat flourbuttermilk solidsCONTAINS MILK AND SOY May contain wheat, peanuts and tree nuts"

J2C Hawaii LLC

FDA FoodClass II

Tiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel. Net wt: Approx: 2 oz (57g). UPC 8 55725 00514 0. Taste of Maui Snacks dba of J2C Hawaii, LLC PO Box 1023, Wailuku HI 96793. The product label is read in parts: INGREDIENTS: SugarWhey Powder, Nonfat Milk Powder, Soy LecithinPeanut Butter (peanuts, peanut oil), Pretzels (wheat flourbuttermilk solidsCONTAINS MILK AND SOY May contain wheat, peanuts and tree nuts"

Ingredients List declares peanut but the Contains statement does not declare peanut

CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,

CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.

Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.

Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845

Medline Industries, LP

Mar 4, 2026Medline Industries, LP

Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.

Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light

MRIMed Inc.

MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light

Due to battery component overheating while charging resulting in melting of internal components and causing smoke.

Mar 4, 2026MRIMed Inc.

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.

Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.

Complaints of the ceramic tip of the resection sheath breaking have been received.

Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528

Medline Industries, LP