FDA daily for Wednesday, August 19, 2026
319 FDA records across 6 sections. 7 touch MedGrid's categories and are listed first.
Drug approvalsCovers FDA's Wed, Aug 12 (a week ago)7
- RIMACTANE
RIFAMPIN — TP ANDA HOLDINGS
- OPDIVO
NIVOLUMAB — BRISTOL MYERS SQUIBB
- FOSFOMYCIN TROMETHAMINE
FOSFOMYCIN TROMETHAMINE — NOVITIUM PHARMA
- DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE — TWI PHARMS
- HEPZATO
MELPHALAN HYDROCHLORIDE — DELCATH SYSTEMS INC
- DUREZOL
DIFLUPREDNATE — SANDOZ
- WINREVAIR
SOTATERCEPT-CSRK — MERCK SHARP DOHME
Drug recallsCovers FDA's Wed, Aug 12 (a week ago)5
- Aurobindo Pharma USA Inc
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-… — shortfill; reports of empty capsules.
- Sunny Pharmtech Inc.
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1 — Presence of Particulate Matter; identified as stainless steel
- Central Admixture Pharmacy Services Inc
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharm… — Incorrect Product Formulation
- Zydus Pharmaceuticals (USA) Inc
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington,… — CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Sunny Pharmtech Inc.
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1 — Presence of Particulate Matter; identified as stainless steel
Food and supplement recallsCovers FDA's Wed, Aug 12 (a week ago)35
- La Colonia Foods Llc
Selectos Latinos Requeson Mexicano Mexican Cottage Cheese, Net Weight 16 oz, packed into retail-sized clear plastic containers. Keep refrigerated. — Products may be contaminated with Listeria monocytogenes.
- Clover Hill Dairy, LLC
Clover Hill Dairy LLP, mild cheese variety (Snack Pack Assorted Regular Mild Stix White Colby, Marble Jack, Yummy Cheddar). Sold in approximate 0.40-lb (6.4oz) units. Unknown information: packaging,… — Product contaminated with Listeria monocytogenes.
- M.G. Foods, Inc.
Spicy Breakfast Burrito sold under the following brand names: FRESH & READY FOODS Spicy Breakfast Burrito Net Wt. 8.2 oz (232g) UPC 1 00001 00029 7 and Sprig & Sprout Spicy Breakfast Burrito IN A SPI… — 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 label.
- Clover Hill Dairy, LLC
Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Jalapeno Cheddar, Pepper Jack, Sizzlin Colby with Habanero Peppers). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb units. Unknown info… — Product contaminated with Listeria monocytogenes.
- FACTORY6, INC.
Zen Principle Naturals Moringa Leaf Powder dietary supplement, 900mg capsules, 180 capsules per PET white bottle. Intended Use: take 2 capsules per day. Route of Administration: OraI. Manufactured fo… — Possible Salmonella in Moringa Leaf Powder product.
- Clover Hill Dairy, LLC
Clover Hill Dairy LLP, Mild Cheese Variety (Yummy Cheddar, White Cheddar, White Colby, Monterey Jack, Marble Jack). Sold in 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb units. Unknown information: packaging… — Product contaminated with Listeria monocytogenes.
- Clover Hill Dairy, LLC
Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Snack Pack Assorted Pepperjack Stix (Jalapeno Cheddar, Pepper Jack)). Sold in approximate 0.40-lb (6.4oz) units. Unknown information: packaging, l… — Product contaminated with Listeria monocytogenes.
- PT Organics Limited
Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree, 4oz/113g pouch, UPC 815367010780, PTO Item 10720. Distributed by: PT Organics Ltd, 333 South State St, Suite V-142, Lake Oswego, OR… — Possible foreign object (thin, soft plastic strands).
- Clover Hill Dairy, LLC
Clover Hill Dairy LLP, Soft Cuajada in Brine, sold in five (5) gallon and two (2) gallon buckets. Unknown information: labeling. Keep refrigerated. — Product contaminated with Listeria monocytogenes.
- Clover Hill Dairy, LLC
Clover Hill Dairy LLP, Sharp Cheese Snack Pack Sharp Stix White or Yellow. Sold in approximate 0.40-lb (6.4oz) units. Unknown information: packaging, labeling, or total quantity of product distribute… — Product contaminated with Listeria monocytogenes.
- Kerry, Inc
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: Kerry Inc, Beloit, WI 53511. — Undeclared allergen (egg)
- Clover Hill Dairy, LLC
Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (3-in-a-Pack Assorted Jalapeno Cheddar, Pepper Jack, Sizzling Colby). Sold in approximate 0.20-lb (3.2oz) units. Unknown information: packaging, la… — Product contaminated with Listeria monocytogenes.
Showing 12 of 35. Search the rest in openFDA.
Device recallsCovers FDA's Wed, Aug 12 (a week ago)1 touch MedGrid79
- Siemens Healthcare Diagnostics, Inc.Touches MedGrid categories
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL — Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is…
- Siemens Healthcare Diagnostics, Inc.
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL — out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to th…
- United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgic… — Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
- Siemens Healthcare Diagnostics, Inc.
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic — Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results;…
- Oxos Medical Inc
Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version: 5.7.0 Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2 )… — Due to a defective circuit board that overheats
- INTEGRATED MEDCRAFT LLC
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. S… — Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
- GE Medical Systems Information Technologies Inc
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph — Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a pre…
- Beckman Coulter Inc.
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-2… — Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
- Freudenberg Medical, LLC
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF — Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
- Freudenberg Medical, LLC
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF — Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
- United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Com… — Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
- AVID Medical, Inc.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15 — Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path h…
Showing 12 of 79. Search the rest in openFDA.
Device clearancesCovers FDA's Wed, Aug 5 (two weeks ago)11
- CAD - Lower GI (EC07-01)
Xiamen Inno Medical Technology Co., Ltd.
- Transurethral Catheter Safety Valve (TUCSV) (80050)
Class Medical , Ltd.
- Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Int…
Convatec
- pVasc Net Mechanical Thrombectomy Device
Vesalio, Inc.
- NaturaJel Oral Wound Care Kit
HCS Innovation, LLC
- Ruthinium Disc
Dental Manufacturing S.p.A.
- Concentriq AP-Dx
Proscia, Inc.
- Rusch Latex Gold Foley Catheter
Teleflex Medical Sdn. Bhd.
- GFS - Sterile Screws and Top Hat
T.A.G. Medical Products Corporation, Ltd.
- Huahong Sharps Container (HHR-I, HHR-II)
Tianjin Huahong Technology Co., Ltd.
- Leksell® Vantage Stereotactic System
Elekta Solutions AB
Label changesCovers FDA's Wed, Aug 5 (two weeks ago)6 touch MedGrid182
- Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30Touches MedGrid categories
Kenvue Brands LLC
- Leader Kids Sport Sunscreen SPF 50Touches MedGrid categories
CARDINAL HEALTH 110, LLC. DBA LEADER
- Lidocaine HydrochlorideTouches MedGrid categories
Hospira, Inc.
- Dealmed BurnTouches MedGrid categories
Dealmed Medical Supplies, LLC.
- Lidocaine HClTouches MedGrid categories
Topco Associates LLC
- Lidocaine Plantar Relief Roll-OnTouches MedGrid categories
Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.
- Ondansetron Hydrochloride
St. Mary's Medical Park Pharmacy
- Drug label
- Drug label
- Glipizide
REMEDYREPACK INC.
- Drug label
- Drug label
Showing 12 of 182. Search the rest in openFDA.
How the FDA Daily Is WrittenSources, dates and what gets flagged
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 recalls, 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. Items that touch the categories MedGrid works in, such as GLP-1s, hormones, injectables, peptides, compounded products and aesthetic devices, are marked and listed first.
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.