FDA daily for Wednesday, October 21, 2026
In this issue: 6 shortage updates, 39 approvals, 34 drug recalls, 6 device recalls, 12 device decisions, 1 label change and 21 food or supplement recalls. 6 items touch categories MedGrid carries, and they come 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.
- QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific pat…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-0…
Apothecary Pharma LLC · Lack of Assurance of Sterility
- Diode Laser Hair Removal Machine (QDTM-03)
Beijing Nubway S&T Co., Ltd. · General, Plastic Surgery
- X10 Natural Enhancement Supplement, 0.5 fl oz/sachet (15 mL), 7 sachets/box, UPC: 7708075247094, Manufactured by FutuPro S.A.S., Colombian…
A&P CREATIONS · Product contains undeclared Sildenafil and Tadalafil.
- biQ-FEL, 16.9 fl oz (500 mL), 17 servings per bottle, Manufactured by ALMENAT SAS AV 39 OESTE No 10 OESTE-18 CALI VALLE INDUSTRIA COLOMBIAN…
A&P CREATIONS · Product contains undeclared Sildenafil and Tadalafil.
Drug shortages
FDA date:FDA updated 6 shortage entries on Tue, Oct 20: 3 new, 3 to be discontinued.
- Enoxaparin Sodium Injection
Sanofi-Aventis U.S. LLC
- Molnupiravir Capsule
Merck Sharp & Dohme LLC
- Leuprolide Acetate Injection
Amneal Pharmaceuticals
- Carboplatin Injection
Teyro Labs · Available
- Methylphenidate Hydrochloride Tablet, Extended Release
Janssen Pharmaceuticals · Available
- Azacitidine Injection
Dr. Reddy's Laboratories, Inc. · Available
Drug and biologic approvals
FDA date:On Wed, Oct 14 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 37 supplements to existing ones.
- LUBIPROSTONE
HUMANWELL PURACAP · LUBIPROSTONE
- AMPHOTERICIN B
QILU PHARM HAINAN · AMPHOTERICIN B
Drug recalls
FDA date:FDA's enforcement report dated Wed, Oct 14 lists 34 drug recalls: 30 Class II, 3 Class III.
- QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific pat…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient pres…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-0…
Apothecary Pharma LLC · Lack of Assurance of Sterility
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Device recalls
FDA date:FDA posted 6 device recalls from 4 firms on Wed, Oct 14.
- PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Ethicon, LLC · Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that…
- RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Steris Corporation · If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemis…
- RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Steris Corporation · If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemis…
- RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
Steris Corporation · If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemis…
- REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
In2bones USA, LLC · Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
- Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VI…
W L Gore & Associates, Inc. · The potential for the devices to be mislabeled with the incorrect length.
Device clearances and approvals
FDA date:FDA decided 10 510(k)s and 2 PMA decisions on Wed, Oct 7.
- Diode Laser Hair Removal Machine (QDTM-03)
Beijing Nubway S&T Co., Ltd. · General, Plastic Surgery
- Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401)
Zhongshan GL Electronics Co. , Ltd. · General, Plastic Surgery
- NeuroDR
Deep Reasoning Ai, Inc. · Radiology
- B. anthracis Real-time PCR Assay
Centers for Disease Control and Prevention · Microbiology
- prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments
Centinel Spine, LLC · Orthopedic
- Ligence Heart
UAB Ligence · Radiology
- eClinics
Ceiba Healthcare US, Inc. · Cardiovascular
- Dr.AlignNavi
InnoDtech, Inc. · Dental
- Vista AI Scan
Vista AI, Inc. · Radiology
- APEX 3D S Diamond Tibia
Paragon 28, Inc. · Orthopedic
Label updates
FDA date:1 drug label took effect on Wed, Oct 7.
Browse label updates in FDA data →Food and supplement recalls
FDA date:FDA's enforcement report dated Wed, Oct 14 lists 21 food or supplement recalls: 7 Class I, 13 Class II.
- X10 Natural Enhancement Supplement, 0.5 fl oz/sachet (15 mL), 7 sachets/box, UPC: 7708075247094, Manufactured by FutuPro S.A.S., Colombian…
A&P CREATIONS · Product contains undeclared Sildenafil and Tadalafil.
- biQ-FEL, 16.9 fl oz (500 mL), 17 servings per bottle, Manufactured by ALMENAT SAS AV 39 OESTE No 10 OESTE-18 CALI VALLE INDUSTRIA COLOMBIAN…
A&P CREATIONS · Product contains undeclared Sildenafil and Tadalafil.
- LEASA Alfalfa Sprouts; packaged in plastic clamshell containers; KEEP REFRIGERATED; NET WT. 6 OZ. (170g); Grown & Packaged by: LEASA Indust…
LEASA Industries Co., Inc. · Seeds may have been contaminated with E.coli
- Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with pink and black lettering; label reads in part as "bettergoods Lemon Alf…
GIAS FOOD INC. · Contamination with Listeria monocytogenes
- Donutful Chocolate Dipped Vanilla Cake Donuts - 7.05oz/10ct.Case Configuration 5 count carton, 6 cartons per case. UPC 850041392103. Paperb…
The Better Bakehouse Snack Company · Undeclared Milk.
- Berlin Seeds Alfalfa Sprouting Seeds, packaged in 1/4 lb., 1/2 lb., 1 lb., and 5 lb. resealable bags and 50 lb. woven poly bags
Berlin Seeds · Product contains alfalfa seed recalled by the supplier due to potential E. coli and/or Salmonella contamination.
- LEASA Living Alfalfa Sprouts; packaged in plastic clamshell containers; KEEP REFRIGERATED; NET WT. 4 OZ. (113g); Grown & Packaged by: LEASA…
LEASA Industries Co., Inc. · Seeds may have been contaminated with E. coli
- QUESO PALMITA. Generic Name: Pastel de Queso (Cheese Pie). Intended use: Human consumption. Condition: Frozen. Shelf life or expected life:…
QUESO PALMITA GP LLC · Undeclared milk, cheese declared
- Saint Francis Apizza Frozen Pepperoni Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic, UPC: 6 66186 27762 1
Saint Francis Apizza LLC · Undeclared soy allergen: soybean oil and soy lecithin
- Chocolate Chip Cookies packaged in a cardboard box; Ingredients: King Midas Special (Wheat flour, niacin, reduced iron, thiamine mononitrat…
J K Patisserie & Bakery LLC · Soy was not declared in the Contains statement.
- WinCo Foods Salsa Bean Dip Express Tray is packaged in a foil bottom container with clear plastic lid. Net Wt. 54oz. UPC 2 67173 510983. Wi…
WinCo Foods LLC · Bean Dip Trays contains recalled Peperoncini (pepper) which was recalled due to pest issue.
- Croissant; packaged in cardboard box; Ingredients: King Midas Special (Wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin,…
J K Patisserie & Bakery LLC · Egg was not declared in the Contains statement.
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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