FDA daily for Wednesday, July 8, 2026
In this issue: 1 shortage update, 22 approvals, 18 drug recalls, 33 device recalls, 28 device decisions, 192 label changes and 45 food or supplement recalls. 8 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.
- LIRAGLUTIDE
SANDOZ · LIRAGLUTIDE
- FINASTERIDE
AUROBINDO PHARMA · FINASTERIDE
- FINASTERIDE
DR REDDYS LABS LTD · FINASTERIDE
- A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Windstone Medical Packaging, Inc. · Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a r…
- A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
Windstone Medical Packaging, Inc. · Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a r…
- Tadalafil
TADALAFIL · Bryant Ranch Prepack · ORAL
- Dried Herring Fish 7 oz.
Prime Food Processing LLC. · Improperly eviscerated which may result in Clostridium botulinum contamination
Drug shortages
FDA date:FDA updated 1 shortage entry on Tue, Jul 7: 1 new, 1 to be discontinued.
- Travoprost Ophthalmic Solution
Mylan Pharmaceuticals Inc., a Viatris Company
Drug and biologic approvals
FDA date:On Wed, Jul 1 FDA approved 5 new applications (0 brand or biologic, 5 generic) and 17 supplements to existing ones.
- LIRAGLUTIDE
SANDOZ · LIRAGLUTIDE
- CHLORTHALIDONE
MACLEODS PHARMS · CHLORTHALIDONE
- RIVAROXABAN
MANKIND PHARMA · RIVAROXABAN
- BRIVARACETAM
SCIEGEN PHARMS · BRIVARACETAM
- BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
SABA ILAC SANAYIVE · BRIMONIDINE TARTRATE, TIMOLOL MALEATE
- FINASTERIDE
AUROBINDO PHARMA · FINASTERIDE
- FINASTERIDE
DR REDDYS LABS LTD · FINASTERIDE
Drug recalls
FDA date:FDA's enforcement report dated Wed, Jul 1 lists 18 drug recalls: 2 Class I, 15 Class II, 1 Class III.
- BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner C…
CareFusion 213, LLC · Non-Sterility: Due to presence of Aspergillus penicillioides.
- BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Ste…
CareFusion 213, LLC · Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the sea…
- Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactu…
Annora Pharma Private Limited · Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
- Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
Amgen, Inc. · Presence of Foreign Substance.
- Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx…
Amgen, Inc. · Presence of Foreign Substance.
- BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Sol…
CareFusion 213, LLC · Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
- Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc.…
Ajanta Pharma USA Inc · CGMP Deviations
- DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
Direct Rx · CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Ste…
CareFusion 213, LLC · Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
- Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx…
Central Admixture Pharmacy Services, Inc. · Incorrect product formulation: bag did not contain copper and famotidine per label.
Device recalls
FDA date:FDA posted 33 device recalls from 10 firms on Wed, Jul 1.
- A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Windstone Medical Packaging, Inc. · Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a r…
- A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
Windstone Medical Packaging, Inc. · Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a r…
- A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Windstone Medical Packaging, Inc. · Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a r…
- A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
Windstone Medical Packaging, Inc. · Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a r…
- Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, posi…
Baxter Healthcare Corporation · There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxyge…
- Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, pos…
Baxter Healthcare Corporation · There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxyge…
- Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, p…
Baxter Healthcare Corporation · There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxyge…
- Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy,…
Baxter Healthcare Corporation · There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxyge…
- IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Hamilton Medical AG · Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the…
- CRE Pro Wireguided 6-8mm 240cm
Boston Scientific Corporation · Potential sterile breach of the pouches in which devices are packaged.
- CRE Pro Wireguided 8-10mm 240cm
Boston Scientific Corporation · Potential sterile breach of the pouches in which devices are packaged.
- CRE Pro Wireguided 10-12mm 240cm
Boston Scientific Corporation · Potential sterile breach of the pouches in which devices are packaged.
Device clearances and approvals
FDA date:FDA decided 15 510(k)s and 13 PMA decisions on Wed, Jun 24.
- HD Camera Head OLYMPUS CH-S200-08-LB
Olympus Medical Systems Corporation · Gastroenterology, Urology
- AMSCO 700 Steam Sterilizer
STERIS Corporation · General Hospital
- Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)
Hangzhou Jimushi Meditech Co., Ltd. · Gastroenterology, Urology
- Enhanced Boundary for PCCT
Ge Medical Systems, LLC · Radiology
- Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019
Hangzhou AGS MedTech Co., Ltd. · Gastroenterology, Urology
- SilverCeuticals® Antimicrobial Wound Gel
Silverceuticals, Inc. · Unknown
- Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)
Shanghai Waylong Intelligent Technology Co.,Ltd · Physical Medicine
- Concerto Versa Detachable Coil
Medtronic, Inc. · Cardiovascular
- ConvaVAC Negative Pressure Wound Therapy System
Convatec Limited, Gdc Building · General, Plastic Surgery
- CLEAR Aspiration System
Insera Therapeutics, Inc. · Unknown
- Ceribell Neurology Review Software
Ceribell, Inc. · Neurology
- Microdacyn Wound Irrigation Solution
Sonoma Pharmaceuticals, Inc. · Unknown
- Target Xtra Detachable Coil
Stryker Neurovscular · Neurology
- Endoform Dermal Template
Aroa Biosurgery , Ltd. · Unknown
Label updates
FDA date:192 drug labels took effect on Wed, Jun 24; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Tadalafil
TADALAFIL · Bryant Ranch Prepack · ORAL
- Lorazepam
LORAZEPAM · REMEDYREPACK INC. · ORAL
- Triamterene and Hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE · Northwind Health Company, LLC · ORAL
- Warfarin Sodium
WARFARIN SODIUM · REMEDYREPACK INC. · ORAL
- Midodrine Hydrochloride
MIDODRINE HYDROCHLORIDE · American Health Packaging · ORAL
- Valsartan and Hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE · Northwind Health Company, LLC · ORAL
- BuPROPion Hydrochloride
BUPROPION HYDROCHLORIDE · American Health Packaging · ORAL
- Sodium Nitroprusside
SODIUM NITROPRUSSIDE · Somerset Therapeutics, LLC · INTRAVENOUS
Food and supplement recalls
FDA date:FDA's enforcement report dated Wed, Jul 1 lists 45 food or supplement recalls: 25 Class I, 19 Class II, 1 Class III.
- Dried Herring Fish 7 oz.
Prime Food Processing LLC. · Improperly eviscerated which may result in Clostridium botulinum contamination
- 1.5oz, 2oz Dirty Brand Salt and Vinegar Potato Chips , Plastic Bag.
Utz Quality Foods, LLC · Potential presence of Salmonella.
- 2.0 oz Dirty Sour Cream and Onion Potato Chips, Plastic Bag.
Utz Quality Foods, LLC · Potential presence of Salmonella.
- 1.5oz Zapp's Bayou Blackened Ranch Kettle Chips, Plastic Bag.
Utz Quality Foods, LLC · Potential presence of Salmonella.
- Spring & Mulberry Mango Chili Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in an orange box, UPC 850055470033, Di…
Spring & Mulberry Inc. · Potential Salmonella contamination
- 6/11oz No Salt Sunflower Seeds
George J Howe Company, Inc. · The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
- Spring & Mulberry Mulberry Fennel Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a burgundy box, UPC 85005547014…
Spring & Mulberry Inc. · Potential Salmonella contamination.
- 25# Sunflower Seeds C/S
George J Howe Company, Inc. · The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
- 2.0 oz Dirty Maui Onion Chip, Plastic Bag.
Utz Quality Foods, LLC · Potential presence of Salmonella.
- Spring & Mulberry Sea Salt Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a grey box, UPC 850055470071, Dist. By…
Spring & Mulberry Inc. · Potential Salmonella contamination
- Spring & Mulberry Lavender Rose Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a light blue box, UPC 85005547001…
Spring & Mulberry Inc. · Potential Salmonella contamination
- Spring & Mulberry Mixed Berry Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a purple box, UPC 850055470026, Dis…
Spring & Mulberry Inc. · Potential Salmonella contamination
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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