Drugs
Class I
Ongoing
Reported Aug 19, 2026
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VM...
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
USA Nationwide
- Firm
- Victory Medical Center Pharmacy
- Recall began
- Jul 1, 2026
- Quantity
- 91
- Codes
- Lot # 1984345, 1980571, 1981940, Use Before Date: 08/27/2026.
- FDA IDs
- D-0772-2026 / event 99509
Drugs
Class I
Ongoing
Reported Aug 19, 2026
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarshei...
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Distributed Nationwide in the US and Mexico.
- Firm
- Liebel-Flarsheim Company LLC
- Recall began
- Jul 31, 2026
- Quantity
- 3,486 500mL-vials
- Codes
- Lot # 25ZF3670, Exp Date: May 31, 2027.
- FDA IDs
- D-0773-2026 / event 99510
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Ino...
CGMP Deviations:Noted during FDA inspection
Distributed Nationwide in the USA
- Firm
- Shoolin Pharma Chem LLP
- Recall began
- Aug 3, 2026
- Quantity
- 25KG, 250-1gm bags
- Codes
- Batch SDC2505001, Date of Expiry: April 30, 2030.
- FDA IDs
- D-0759-2026 / event 99547
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65...
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Nationwide within the U.S
- Firm
- Apollo Care, LLC
- Recall began
- Jul 29, 2026
- Quantity
- 250 vials.
- Codes
- Lot: AC-017273, Exp. 12/12/2026.
- FDA IDs
- D-0755-2026 / event 99505
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Nationwide within the U.S
- Firm
- Apollo Care, LLC
- Recall began
- Jul 29, 2026
- Quantity
- 56,918 vials.
- Codes
- Lot: AC-017108, Exp. 11/17/2026; AC-017110, Exp. 11/20/2026; AC-017112, Exp. 11/21/2026; AC-017142, AC-017144, Exp. 12/10/2026; AC-017166, AC-017167, AC-017177, AC-017213, AC-01722...
- FDA IDs
- D-0747-2026 / event 99505
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Nationwide within the U.S
- Firm
- Apollo Care, LLC
- Recall began
- Jul 29, 2026
- Quantity
- 23,029 vials.
- Codes
- Lot: AC-017114, Exp. 11/24/2026; AC-017164, AC-017204, AC-017205, Exp. 12/31/2026.
- FDA IDs
- D-0748-2026 / event 99505
Drugs
Class II
Ongoing
Reported Aug 19, 2026
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Nationwide within the U.S
- Firm
- Heritage Pharmaceuticals Inc
- Recall began
- Jul 30, 2026
- Quantity
- Not specified
- Codes
- Lot #: 2411550, Exp. 2026/NOV.
- FDA IDs
- D-0768-2026 / event 99526
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65...
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Nationwide within the U.S
- Firm
- Apollo Care, LLC
- Recall began
- Jul 29, 2026
- Quantity
- 250 vials.
- Codes
- Lot: AC-017271, Exp. 12/12/2026.
- FDA IDs
- D-0753-2026 / event 99505
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Nationwide within the U.S
- Firm
- Apollo Care, LLC
- Recall began
- Jul 29, 2026
- Quantity
- 37,546 vials.
- Codes
- Lot: C-017115, Exp. 11/25/2026; AC-017163, Exp. 12/31/2026; AC-017169, AC-017170, AC-017171, Exp. 12/31/2026; AC-017230, AC-017231, Exp. 5/5/2027.
- FDA IDs
- D-0749-2026 / event 99505
Drugs
Class II
Ongoing
Reported Aug 19, 2026
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Nationwide within the U.S
- Firm
- Apollo Care, LLC
- Recall began
- Jul 29, 2026
- Quantity
- 4,748 vials.
- Codes
- Lot: AC-017131, Exp. 8/30/2026.
- FDA IDs
- D-0752-2026 / event 99505
Drugs
Class II
Ongoing
Reported Aug 19, 2026
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC...
Lack of assurance of sterility. The recall is due to potential contamination
Nationwide in the USA.
- Firm
- Prestige Brands Holdings
- Recall began
- Jul 29, 2026
- Quantity
- 39,060 15mL-bottles
- Codes
- Lot 2552A, Exp 09/30/2027
- FDA IDs
- D-0766-2026 / event 99532
Devices
Class II
Ongoing
Reported Aug 19, 2026
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may b...
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
U.S. Nationwide distribution in the states of GA and RI.
- Firm
- W L Gore & Associates, Inc.
- Recall began
- May 22, 2026
- Quantity
- 13 units
- Codes
- Incorrect Catalogue Number/UDI: VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN1010 / 00733132638888, VSWVN101...
- FDA IDs
- Z-2914-2026 / event 99143
Devices
Class II
Ongoing
Reported Aug 19, 2026
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog...
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
US Nationwide. Canada.
- Firm
- Cardinal Health 200, LLC
- Recall began
- Jul 14, 2026
- Quantity
- 87182 kits
- Codes
- 1) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 2) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 3) 24-0726A,...
- FDA IDs
- Z-2945-2026 / event 99380
Devices
Class II
Ongoing
Reported Aug 19, 2026
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPAS...
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary,...
- Firm
- Covidien, LP
- Recall began
- Jun 24, 2026
- Quantity
- 135,875 total
- Codes
- BOX06614V4 UDI-DI 00199150037902 Lots 0233506453 0233506454 0233506455 0233506456 BOX07405V1 UDI-DI 00763000960186 Lot 0233617676 BOX01056V2 UDI-DI 00763000593711 Lot 0233484641 BO...
- FDA IDs
- Z-2919-2026 / event 99390
Devices
Class II
Ongoing
Reported Aug 19, 2026
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter int...
Due to an increase rate of balloon pinhole defects.
Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI. The countries of Europe - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland...
- Firm
- MICROVENTION INC.
- Recall began
- Apr 30, 2026
- Quantity
- 5500 devices
- Codes
- Catalog Number: BOB-895-CN UDI codes: (01)00842429111062(11)250819(17)280731(10)0001218734 (01)00842429111062(11)250822(17)280731(10)0001222844 (01)00842429111062(11)250825(17)2807...
- FDA IDs
- Z-2912-2026 / event 98909
Devices
Class II
Ongoing
Reported Aug 19, 2026
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
US Nationwide. Canada.
- Firm
- Cardinal Health 200, LLC
- Recall began
- Jul 14, 2026
- Quantity
- 456 kits
- Codes
- 1) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:12206¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 2) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot...
- FDA IDs
- Z-2943-2026 / event 99380
Devices
Class II
Ongoing
Reported Aug 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectivene...
US Nationwide distribution in the states and territories of Guam, Puerto Rico.
- Firm
- Medline Industries, LP
- Recall began
- Jun 30, 2026
- Quantity
- 31,728
- Codes
- UDI-DI (each) 00193489015242, UDI-DI (case) 20193489015246, Lot Numbers: All lots produced between 05/27/2025 and 04/10/2026
- FDA IDs
- Z-2926-2026 / event 99432
Devices
Class II
Ongoing
Reported Aug 19, 2026
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN3...
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
US Nationwide. Canada.
- Firm
- Cardinal Health 200, LLC
- Recall began
- Jul 14, 2026
- Quantity
- 52699 kits
- Codes
- 1) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 2) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 3) P...
- FDA IDs
- Z-2948-2026 / event 99380
Devices
Class II
Ongoing
Reported Aug 19, 2026
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Firmware issue potentially leading to loss of geometry movements.
Worldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, Fra...
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Recall began
- Jun 29, 2026
- Quantity
- 4,252 units
- Codes
- Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)0088...
- FDA IDs
- Z-2928-2026 / event 99378
Devices
Class II
Ongoing
Reported Aug 19, 2026
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial...
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Worldwide distribution - US Nationwide and the country of Canada.
- Firm
- Terumo Medical Corporation
- Recall began
- Jun 15, 2026
- Quantity
- 7,490 units
- Codes
- Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
- FDA IDs
- Z-2930-2026 / event 99285
Devices
Class II
Ongoing
Reported Aug 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectivene...
US Nationwide distribution in the states and territories of Guam, Puerto Rico.
- Firm
- Medline Industries, LP
- Recall began
- Jun 30, 2026
- Quantity
- 1,244 units
- Codes
- UDI-DI (each) 80080196314521, UDI-DI (case) 10080196314522, Lot Numbers: All lots produced between 10/27/2025 and 11/19/2025
- FDA IDs
- Z-2925-2026 / event 99432
Devices
Class II
Ongoing
Reported Aug 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectivene...
US Nationwide distribution in the states and territories of Guam, Puerto Rico.
- Firm
- Medline Industries, LP
- Recall began
- Jun 30, 2026
- Quantity
- 447,618 units
- Codes
- UDI-DI (each) 10888277652521, UDI-DI (case) 20888277652528, Lot Numbers: All lots produced between 05/13/2025 and 04/21/2026
- FDA IDs
- Z-2924-2026 / event 99432