FDA daily for Wednesday, November 26, 2025
In this issue: 15 approvals, 28 device recalls, 11 device decisions, 170 label changes and 22 food or supplement recalls. 1 item touches categories MedGrid carries, and it comes first.
For MedGrid's categories
Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.
- Testosterone Cypionate
TESTOSTERONE CYPIONATE · Bryant Ranch Prepack · INTRAMUSCULAR
Drug and biologic approvals
FDA date:On Wed, Nov 19 FDA approved 5 new applications (1 brand or biologic, 4 generic) and 10 supplements to existing ones.
- NILOTINIB HYDROCHLORIDE
DR REDDYS · NILOTINIB HYDROCHLORIDE
- HYRNUO
BAYER HEALTHCARE · SEVABERTINIB
- NILOTINIB HYDROCHLORIDE, NILOTINIB HYDROCHLORIDE DIHYDRATE
HETERO LABS LTD V · NILOTINIB HYDROCHLORIDE, NILOTINIB HYDROCHLORIDE DIHYDRATE
- NILOTINIB HYDROCHLORIDE
MSN · NILOTINIB HYDROCHLORIDE
- DOXYCYCLINE HYCLATE
MACLEODS PHARMS · DOXYCYCLINE HYCLATE
Device recalls
FDA date:FDA posted 28 device recalls from 4 firms on Wed, Nov 19.
- MONARCH Bronchoscope. Model Number: MBR-000211-B
Auris Health, Inc · Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
- SAFE-T-FILL Micro Capillary Blood Collection, 125 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description…
ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 712…
ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 712…
ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: T…
ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: T…
ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- AFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07…
ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07…
ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description…
ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description…
ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description:…
ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Produ…
ASP Global, LLC. dba Anatomy Supply Partners, LLC. · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Device clearances and approvals
FDA date:FDA decided 10 510(k)s and 1 PMA decision on Wed, Nov 12.
- CMORE® CT System; CMORE® CT System Navigated Instruments
Icotec AG · Orthopedic
- EMPOWR Acetabular® Liner Extension
Encore Medical L.P. · Orthopedic
- Hemoclip
Hangzhou AGS MedTech Co., Ltd. · Gastroenterology, Urology
- Synthes Patient Specific Implants
Synthes GmbH · Neurology
- PeekMed web
Peek Health, S.A. · Radiology
- VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
Olympus Medical Systems Corp. · Gastroenterology, Urology
- WRISTAR MultiAx Distal Radius Kit
Intrauma S.P.A · Orthopedic
- PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
ETHICON, Inc. · General, Plastic Surgery
- XSTAT P15
Revmedx, Inc. · General, Plastic Surgery
- Powered Wheelchair (PL001-9001)
Suzhou KD Intelligent Device Co., Ltd. · Physical Medicine
Label updates
FDA date:170 drug labels took effect on Wed, Nov 12; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Testosterone Cypionate
TESTOSTERONE CYPIONATE · Bryant Ranch Prepack · INTRAMUSCULAR
- Microgestin 1/20
NORETHINDRONE ACETATE/ETHINYL ESTRADIOL · Mayne Pharma Inc.
- CLOPIDOGREL
CLOPIDOGREL BISULFATE · Novadoz Pharmaceuticals LLC · ORAL
Food and supplement recalls
FDA date:FDA's enforcement report dated Wed, Nov 19 lists 22 food or supplement recalls: 15 Class I, 7 Class II.
- Item IL1014A, PIGGY Lotte Crispy Crunch Ice Cream Cone, Strawberry flavor, Keep Frozen, (4/5/160ML), UPC 8801118255045. Product of Korea. T…
Seoul Trading, Inc. · Undeclared peanut.
- Carton Label: PACIFIC FRESH VEGETABLES PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 Carton Sticker Label: Conv Italian Parsley 60 Ct C…
Pacific International Marketing · Potential contamination with Salmonella.
- Peach Salsa - $5.99-16 oz 639123940636 packaged in clear plastic clamshells Sell by 11/3/2025 Sell by 11/4/2025
JFE FRANCHISING INC · Peaches provided by Moonlight Peaches potentially contaminated with Listeria.
- Peach Salsa; UPC 85006540364 14oz (397g); Use by 10/12/2025 to 10/29/2025
GBC Food Services, LLC · Peaches provided by Moonlight Peaches potentially contaminated with Listeria.
- Carton Label: PACIFIC STRAIGHT FROM THE FIELDS FRESH HERBS 4/24 BUNCH ITALIAN PARSLEY BAGS PRODUCE OF U.S.A. PACIFIC INTERNATIONAL MARKETIN…
Pacific International Marketing · Potential contamination with Salmonella.
- LO-BOY FOODS; TUNA DELUXE; packaged in 5lb white plastic tubs
Made Fresh Salads Inc · Products may be contaminated with Listeria monocytogenes.
- Carton Label: PACIFIC FRESH VEGETABLES PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 PRODUCE OF U.S.A. Sticker Label: Conv Italian Pars…
Pacific International Marketing · Potential contamination with Salmonella.
- Zingerman's Peanut Butter Crush Candy Bar net wt 2oz UPC 844397005237
Zingerman's Coffee Company · Undeclared cashew
- Monarch Premium Kratom Green Maeng Da powder is packaged in seal mylar pouches: Monarch Premium Kratom Green Maeng Da, 4oz powder (112g), U…
Lotus Vaping Technologies, LLC · Product has the potential to be contaminated with Salmonella
- Monarch Premium Kratom White Elephant powder is packaged in seal mylar pouches: Monarch Premium Kratom, White Elephant, 4oz powder (112g),…
Lotus Vaping Technologies, LLC · Product has the potential to be contaminated with Salmonella
- Zingerman's Ca$hew Cow Candy Bar net wt 2oz UPC 844397000157
Zingerman's Coffee Company · Undeclared peanut
- LO-BOY FOODS; MACARONI SALAD; packaged in 5lb white plastic tubs
Made Fresh Salads Inc · Products may be contaminated with Listeria monocytogenes.
FDA did not answer for Drug recalls, Drug shortages while this issue was written; those sections will fill in on a later visit.
How the FDA daily is written
Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.
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