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Pharmaceutical
FDA Drugs
FDA DrugsNilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17
Cipla USA, Inc.
FDA DrugsClass III
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Mar 11, 2026Cipla USA, Inc.
Medical DeviceFDA Devices
FDA DevicesBrand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Advanced Bionics, LLC
FDA DevicesClass II
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Behind-the-ear sound processer packaging label is different then included product.
Mar 11, 2026Advanced Bionics, LLC
FSANZ FoodFood Safety
Family Select Pty Ltd - Frozen Sorbet Mango 75g, Strawberry 75g and Lychee 75g
The recall is due to the presence of an undeclared allergen (milk).
Mar 11, 2026Family Select Pty Ltd
PharmaceuticalFDA Drugs
FDA DrugsTirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
New Life Pharma LLC
FDA DrugsClass II
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
Lack of Assurance of Sterility
Mar 11, 2026New Life Pharma LLC
PharmaceuticalFDA Drugs
FDA DrugsDynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.
ACME UNITED CORPORATION
FDA DrugsClass II
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.
CGMP Deviations
Mar 11, 2026ACME UNITED CORPORATION
Medical DeviceFDA Devices
FDA DevicesBrand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
B Braun Medical Inc
FDA DevicesClass II
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Mar 11, 2026B Braun Medical Inc
Food & BeverageFDA Food
FDA Foodtippy toes apple pear banana 6 months & up baby food 2-4OZ (113g) PACKS NET WT 8 OZ (226g) DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 1-888-423-0139 PRODUCT OF USA UPC: 036800265783
IF Holding II, LLC
FDA FoodClass II
tippy toes apple pear banana 6 months & up baby food 2-4OZ (113g) PACKS NET WT 8 OZ (226g) DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 1-888-423-0139 PRODUCT OF USA UPC: 036800265783
Potential contamination with patulin.
Mar 11, 2026IF Holding II, LLC
PharmaceuticalFDA Drugs
FDA DrugsMed-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC 0924-0243-01.
ACME UNITED CORPORATION
FDA DrugsClass II
Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC 0924-0243-01.
CGMP Deviations
Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalFDA Drugs
FDA DrugsAmnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
MYLAN PHARMACEUTICALS INC
FDA DrugsClass II
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
Failed Dissolution Specifications
Mar 11, 2026MYLAN PHARMACEUTICALS INC
Medical DeviceFDA Devices
FDA DevicesCS100 IABP. Software Version CS100 IABP Q.01.
Datascope Corp.
FDA DevicesClass II
CS100 IABP. Software Version CS100 IABP Q.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Mar 11, 2026Datascope Corp.
PharmaceuticalFDA Drugs
FDA DrugsMR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
StuffbyNainax
FDA DrugsClass I
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Mar 11, 2026StuffbyNainax
Medical DeviceFDA Devices
FDA DevicesBrand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Olympus Corporation of the Americas
FDA DevicesClass II
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Mar 11, 2026Olympus Corporation of the Americas
PharmaceuticalFDA Drugs
FDA DrugsDynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01
ACME UNITED CORPORATION
FDA DrugsClass II
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01
CGMP Deviations
Mar 11, 2026ACME UNITED CORPORATION
Medical DeviceFDA Devices
FDA DevicesEsaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
ESAOTE S.P.A.
FDA DevicesClass II
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
Mar 11, 2026ESAOTE S.P.A.
Vehicle RecallNHTSA
NHTSAVolvo Car USA, LLC - Seat Belt Warning System Malfunction/FMVSS 208
Volvo Car USA, LLC
NHTSASEAT BELTS
Volvo Car USA, LLC - Seat Belt Warning System Malfunction/FMVSS 208
An audible warning chime that does not properly alert of an unbelted seat belt can increase the risk of injury during a crash.
Mar 11, 2026Volvo Car USA, LLC
PharmaceuticalFDA Drugs
FDA DrugsFirst Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00.
ACME UNITED CORPORATION
FDA DrugsClass II
First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00.
CGMP Deviations
Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalFDA Drugs
FDA DrugsSemaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.
New Life Pharma LLC
FDA DrugsClass II
Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.
Lack of Assurance of Sterility
Mar 11, 2026New Life Pharma LLC
PharmaceuticalFDA Drugs
FDA DrugsWipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01.
ACME UNITED CORPORATION
FDA DrugsClass II
Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01.
CGMP Deviations
Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalFDA Drugs
FDA DrugsTirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
New Life Pharma LLC
FDA DrugsClass II
Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
Lack of Assurance of Sterility
Mar 11, 2026New Life Pharma LLC
PharmaceuticalFDA Drugs
FDA DrugsProduct label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Rising Pharma Holding, Inc.
FDA DrugsClass II
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Mar 11, 2026Rising Pharma Holding, Inc.
PharmaceuticalFDA Drugs
FDA DrugsFirst Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04
ACME UNITED CORPORATION
FDA DrugsClass II
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04
CGMP Deviations
Mar 11, 2026ACME UNITED CORPORATION
Medical DeviceFDA Devices
FDA DevicesGE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
GE Healthcare
FDA DevicesClass II
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,
Mar 11, 2026GE Healthcare
FSANZ FoodFood Safety
UPDATED 12.03.26 | Datah International (Aust) Pty Ltd - Vadilal Grated Coconut 312g
The presence of a viral (Hepatitis A) contamination.
Mar 11, 2026UPDATED 12.03.26 | Datah International (Aust) Pty Ltd
Medical Device
Australia
AustraliaRifton TRAM and E-Pacer patient transfer and gait training devices
TGA
au-tgaMedical Device ...
Rifton TRAM and E-Pacer patient transfer and gait training devices
Apex Mobility is conducting a product correction on the Rifton TRAM and E-Pacer patient transfer and gait training mobility devices....
Mar 11, 2026TGA