FDA daily for Wednesday, August 19, 2026
In this issue: 3 shortage updates, 7 approvals, 5 drug recalls, 3 device recalls, 21 device decisions, 182 label changes and 35 food or supplement recalls. 4 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.
- OPDIVO
BRISTOL MYERS SQUIBB · NIVOLUMAB
- Huahong Sharps Container (HHR-I, HHR-II)
Tianjin Huahong Technology Co., Ltd. · General Hospital
- Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30, Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Gleam 40 +2
AVOBENZONE, HOMOSALATE, OCTOCRYLENE · Kenvue Brands LLC · TOPICAL
- Ashfiat Alharamain Energy Support 250ml/8fl. oz.
AKKARCO LLC · Undeclared tadalafil
Drug shortages
FDA date:FDA updated 3 shortage entries on Tue, Aug 18: 3 status updates.
- Ropivacaine Hydrochloride Injection
InfoRLife SA · Limited Availability · Reason: Other
- Metronidazole Injection
InfoRLife SA · Limited Availability · Reason: Other
- Dexmedetomidine Hydrochloride Injection
Par Health, USA LLC · Available
Drug and biologic approvals
FDA date:On Wed, Aug 12 FDA approved 1 new application (0 brand or biologic, 1 generic) and 6 supplements to existing ones.
- FOSFOMYCIN TROMETHAMINE
NOVITIUM PHARMA · FOSFOMYCIN TROMETHAMINE
- OPDIVO
BRISTOL MYERS SQUIBB · NIVOLUMAB
Drug recalls
FDA date:FDA's enforcement report dated Wed, Aug 12 lists 5 drug recalls: 2 Class I, 2 Class II, 1 Class III.
- Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemon…
Sunny Pharmtech Inc. · Presence of Particulate Matter; identified as stainless steel
- Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemon…
Sunny Pharmtech Inc. · Presence of Particulate Matter; identified as stainless steel
- Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown…
Aurobindo Pharma USA Inc · shortfill; reports of empty capsules.
- Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, D…
Zydus Pharmaceuticals (USA) Inc · CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dos…
Central Admixture Pharmacy Services Inc · Incorrect Product Formulation
Device recalls
FDA date:FDA posted 3 device recalls from 3 firms on Wed, Aug 12.
- BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
BioFire Diagnostics, LLC · Due to increase in false negative results
- ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Bioporto Diagnostics A/S · The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inapp…
- ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Erbe USA Inc · A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in C…
Device clearances and approvals
FDA date:FDA decided 11 510(k)s and 10 PMA decisions on Wed, Aug 5, including 1 original PMA.
- DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens
Tianjin MasterVision Technology Co., Ltd. · Lens, contact, orthokeratology, overnight · Ophthalmic
- Huahong Sharps Container (HHR-I, HHR-II)
Tianjin Huahong Technology Co., Ltd. · General Hospital
- Concentriq AP-Dx
Proscia, Inc. · Pathology
- CAD - Lower GI (EC07-01)
Xiamen Inno Medical Technology Co., Ltd. · Gastroenterology, Urology
- Transurethral Catheter Safety Valve (TUCSV) (80050)
Class Medical , Ltd. · Gastroenterology, Urology
- Rusch Latex Gold Foley Catheter
Teleflex Medical Sdn. Bhd. · Gastroenterology, Urology
- pVasc Net Mechanical Thrombectomy Device
Vesalio, Inc. · Unknown
- Leksell® Vantage Stereotactic System
Elekta Solutions AB · Neurology
- NaturaJel Oral Wound Care Kit
HCS Innovation, LLC · Unknown
- GFS - Sterile Screws and Top Hat
T.A.G. Medical Products Corporation, Ltd. · Orthopedic
- Ruthinium Disc
Dental Manufacturing S.p.A. · Dental
Label updates
FDA date:182 drug labels took effect on Wed, Aug 5; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30, Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Gleam 40 +2
AVOBENZONE, HOMOSALATE, OCTOCRYLENE · Kenvue Brands LLC · TOPICAL
- Enalapril Maleate
ENALAPRIL MALEATE · Golden State Medical Supply, Inc. · ORAL
- Valsartan
VALSARTAN · Macleods Pharmaceuticals Limited · ORAL
Food and supplement recalls
FDA date:FDA's enforcement report dated Wed, Aug 12 lists 35 food or supplement recalls: 27 Class I, 7 Class II, 1 Class III.
- Ashfiat Alharamain Energy Support 250ml/8fl. oz.
AKKARCO LLC · Undeclared tadalafil
- Selectos Latinos Requeson Mexicano Mexican Cottage Cheese, Net Weight 16 oz, packed into retail-sized clear plastic containers. Keep refrig…
La Colonia Foods Llc · Products may be contaminated with Listeria monocytogenes.
- Clover Hill Dairy LLP, mild cheese variety (Snack Pack Assorted Regular Mild Stix White Colby, Marble Jack, Yummy Cheddar). Sold in approxi…
Clover Hill Dairy, LLC · Product contaminated with Listeria monocytogenes.
- Spicy Breakfast Burrito sold under the following brand names: FRESH & READY FOODS Spicy Breakfast Burrito Net Wt. 8.2 oz (232g) UPC 1 00001…
M.G. Foods, Inc. · Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the la…
- Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Jalapeno Cheddar, Pepper Jack, Sizzlin Colby with Habanero Peppers). Sold in approxima…
Clover Hill Dairy, LLC · Product contaminated with Listeria monocytogenes.
- Zen Principle Naturals Moringa Leaf Powder dietary supplement, 900mg capsules, 180 capsules per PET white bottle. Intended Use: take 2 caps…
FACTORY6, INC. · Possible Salmonella in Moringa Leaf Powder product.
- Clover Hill Dairy LLP, Mild Cheese Variety (Yummy Cheddar, White Cheddar, White Colby, Monterey Jack, Marble Jack). Sold in 1/2-lb, 1-lb, 2…
Clover Hill Dairy, LLC · Product contaminated with Listeria monocytogenes.
- Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Snack Pack Assorted Pepperjack Stix (Jalapeno Cheddar, Pepper Jack)). Sold in approxim…
Clover Hill Dairy, LLC · Product contaminated with Listeria monocytogenes.
- Clover Hill Dairy LLP, Soft Cuajada in Brine, sold in five (5) gallon and two (2) gallon buckets. Unknown information: labeling. Keep refri…
Clover Hill Dairy, LLC · Product contaminated with Listeria monocytogenes.
- Clover Hill Dairy LLP, Sharp Cheese Snack Pack Sharp Stix White or Yellow. Sold in approximate 0.40-lb (6.4oz) units. Unknown information:…
Clover Hill Dairy, LLC · Product contaminated with Listeria monocytogenes.
- KC Everyday Mac & Cheese, 3lb x 6. Item # 20609055. 6 - 3 lb pouches, Net Wt: 18 lb. (8.16Kg). Fully Cooked. Keep Frozen. Distributed By: K…
Kerry, Inc · Undeclared allergen (egg)
- Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (3-in-a-Pack Assorted Jalapeno Cheddar, Pepper Jack, Sizzling Colby). Sold in approxima…
Clover Hill Dairy, LLC · Product contaminated with Listeria monocytogenes.
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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