FDA daily for Wednesday, September 16, 2026
313 FDA records across 7 sections. 13 touch MedGrid's categories and are listed first.
Drug shortagesCovers FDA's Tue, Sep 15 (yesterday)29
- Lisdexamfetamine Dimesylate Capsule
Vyvanse, Capsule, 20 mg (NDC 59417-102-10) — Takeda Pharmaceuticals USA Inc.
- Dexmedetomidine Hydrochloride Injection
Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) — Accord Healthcare Inc.
- Triamcinolone Hexacetonide Injection
Hexatrione, Injection, 40 mg/2 mL (NDC 59137-570-01) — Medexus
- Morphine Sulfate Injection
Mitigo, Injection, 500 mg/20 mL (NDC 66794-162-02) — Piramal Critical Care Inc.
- Morphine Sulfate Injection
Mitigo, Injection, 200 mg/20 mL (NDC 66794-160-02) — Piramal Critical Care Inc.
- Lisdexamfetamine Dimesylate Tablet, Chewable
Vyvanse, Tablet, Chewable, 30 mg (NDC 59417-117-01) — Takeda Pharmaceuticals USA Inc.
- Lisdexamfetamine Dimesylate Capsule
Vyvanse, Capsule, 40 mg (NDC 59417-104-10) — Takeda Pharmaceuticals USA Inc.
- Flurazepam Hydrochloride Capsule
Flurazepam Hydrochloride, Capsule, 15 mg (NDC 62135-736-90) — Chartwell Molecular Holdings LLC
- Rocuronium Bromide Injection
Rocuronium Bromide, Injection, 100 mg/10 mL (NDC 66794-229-41) — Piramal Critical Care Inc.
- Dexmedetomidine Hydrochloride Injection
Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-432-93) — Accord Healthcare Inc.
- Lisdexamfetamine Dimesylate Tablet, Chewable
Vyvanse, Tablet, Chewable, 20 mg (NDC 59417-116-01) — Takeda Pharmaceuticals USA Inc.
- Lisdexamfetamine Dimesylate Capsule
Vyvanse, Capsule, 60 mg (NDC 59417-106-10) — Takeda Pharmaceuticals USA Inc.
Showing 12 of 29. Search the rest in openFDA.
Drug approvalsCovers FDA's Wed, Sep 9 (a week ago)3
- HYRNUO
SEVABERTINIB — BAYER HEALTHCARE
- ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE — ALEMBIC LTD
- AMELUZ
AMINOLEVULINIC ACID HYDROCHLORIDE — BIOFRONTERA
Drug recallsCovers FDA's Wed, Sep 9 (a week ago)5 touch MedGrid34
- OPTIMAL BALANCE PHARMACYTouches MedGrid categories
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Ba… — Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
- Allies Group Inc.Touches MedGrid categories
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte L… — Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Allies Group Inc.Touches MedGrid categories
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914… — Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Allies Group Inc.Touches MedGrid categories
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. U… — Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Allies Group Inc.Touches MedGrid categories
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 0689… — Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
- Baxter Healthcare Corporation
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC… — CGMP Deviations
- Baxter Healthcare Corporation
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-96… — CGMP Deviations
- Baxter Healthcare Corporation
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfiel… — CGMP Deviations
- Baxter Healthcare Corporation
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, De… — CGMP Deviations
- Supernus Pharmaceuticals, Inc.
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc… — Failed dissolution specifications.
- American Health Packaging
Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481… — Labeling: Label Mix-up
- Teva Pharmaceuticals USA, Inc
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC… — Presence of Foreign Tablets/Capsules
Showing 12 of 34. Search the rest in openFDA.
Food and supplement recallsCovers FDA's Wed, Sep 9 (a week ago)19
- Prince Bakery Inc
Prince ITALIAN BREAD; Sesame; ITALIAN & FRENCH BREAD, LARGE; NET WEIGHT 12 OZ. (340g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR< NIACIN, FERROUS SULFATE, THIAMINE MONONITR… — Sesame is not declared in the ingredient statement but is declared in the statement of identity.
- Ukrop's Homestyle Foods LLC
Bread Pudding with Vanilla Sauce - KIT NET WT 4 LB (1.81Kg) UPC 7 22515 91732 0 Ukrop's Homestyle Foods, LLC Richmond, VA 23230 — Foreign object: metal fragments
- Wonton Specialists
Wonton Specialist Inc. Pan Fried Noodle, 16 oz and 5lb packaged in clear plastic bags — Undeclared FD&C Red No. 40
- Wonton Specialists
Wonton Specialist Inc. Cooked Noodle, 16 oz and 5 lb - packaged in clear plastic bags — Undeclared FD&C Red No. 40
- Fayus Inc.
OLA-OLA Pounded Yam (Iyan) IYANINSTANT, NET WT. 2 lbs., 4 lbs., 5 lbs., 10 lbs, packed in flexible plastic bags. INGREDIENTS: Processed Dehydrated Yam Flour, freshness preserved by BHT & sodium bisul… — Undeclared milk.
- WEIS MARKETS, INC.
Weis (Fresh From the Orchard ) Pasteurized Apple Cider, Contains 100 % Juice, the product comes in the following sizes: Pints, 1/2 Gallon, Gallon, plastic jug. 6 1/2 - gallon jugs per crate. — Product has high patulin levels
- Prince Bakery Inc
Prince ITALIAN BREAD; Sesame; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR, NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID, POTA… — Sesame is not declared in the ingredient statement but is declared in the statement of identity.
- Marina Del Rey Foods inc.
Frankie's Organic Plant-Based Puffs Vegan Cheddar, NET WT. 4 oz. (113 g). Product is packaged into flexible plastic bag, UPC 816929000119. Sold wholesale: 12 retail units/ case — Product tested positive for undeclared milk.
- Ukrop's Homestyle Foods LLC
Bread Pudding with Vanilla Sauce NET WT 13.8 OZ (39g) UPC 7 22515 28044 8 Ukrop's Homestyle Foods, LLC Richmond, VA 23230 — Foreign object: metal fragments
- THE HAMPTON GROCER
THE HAMPTON GROCER brand; Lacnola; SMALL BATCH LACTATION GRANOLA, 8oz, stand up pouches; NUTRIENT DENSE INGREDIENTS + MORINGA; SUPPORTS + PROMOTES HEALTHY LACTATION; INGREDIENTS Organic Gluten Free O… — Product may be contaminated with Salmonella.
- Prince Bakery Inc
Prince PAN DE MANTECA; SPANISH STYLE; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR, NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC AC… — Milk is not declared in the Contains statement.
- Ron's Home Style Foods, Inc.
Item #DIPSAU0205RFS Salsa Autentica 5 lb. packaged in round plastic container. — Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella
Showing 12 of 19. Search the rest in openFDA.
Device recallsCovers FDA's Wed, Sep 9 (a week ago)3 touch MedGrid64
- AVID Medical, Inc.Touches MedGrid categories
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Numbe… — The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected varia…
- AVID Medical, Inc.Touches MedGrid categories
Halyard medical convenience kits labeled as: 1) ENT, Model/Item Number (kit) ACEN89-01; 2) ENT, Model/Item Number (kit) ACEN89-02; 3) BACK PACK, Model/Item Number (kit) ALBK51-01; 4) DR DERIAN SPINE… — The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected varia…
- AVID Medical, Inc.Touches MedGrid categories
1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03; 7) NEURO L… — The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected varia…
- Medline Industries, LP
Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487A — The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the…
- Diagnostica Stago, Inc.
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test — A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
- Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II 170032 ; 3) SMA… — The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effe…
- Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD; 2) KIT, GYN ROBOT ACCESSORY , Catalog Number: PB35GYBJC; 3… — The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effe…
- Fresenius Medical Care Renal Therapies Group, LLC
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 — Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
- Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3; 2) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM4; 3) KIT, C SE… — The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effe…
- Johnson & Johnson Surgical Vision, Inc.
HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10301012 (EU); HEALON DUET PRO II, REF: 10301016 (EU) — Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion…
- Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D — The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effe…
- Boston Scientific Corporation
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8) — There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluatio…
Showing 12 of 64. Search the rest in openFDA.
Device clearancesCovers FDA's Wed, Sep 2 (two weeks ago)1 touch MedGrid14
- 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Touches MedGrid categories
Zhengzhou PZ Laser Slim Technology Co., Ltd.
- I-View®
Hologic, Inc.
- Ellian Enigma RF Device
Ellian Corp
- ArthroTAK Tendon Anchor Kit
ArthroTAK, LLC
- Trexo Theo
Trexo Robotics, Inc.
- Aevumed SUPERCYNCH Button System
Aevumed, Inc.
- Vivid Explorer/Vivid Advanced/Vivid Focus
GE Medical Systems Ultrasound and Primary Care Diagnostics
- Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Cardinalhealth
- Pivot Insulin Delivery System
Modular Medical, Inc.
- 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large…
Flexicare Medical Limited.
- Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
Serpex Medical
- HYALOMATRIX
Anika Therapeutics, Inc.
Showing 12 of 14. Search the rest in openFDA.
Label changesCovers FDA's Wed, Sep 2 (two weeks ago)4 touch MedGrid150
- XYLOCAINE MPFTouches MedGrid categories
HF Acquisition Co LLC, DBA HealthFirst
- WALMART EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUMTouches MedGrid categories
WALMART, INC.
- HUSTLE BUTTER NUMBINGTouches MedGrid categories
H.B.D. DIST. INC.
- Chantecaille Ultra Sun Protection Sunscreen SPF 45Touches MedGrid categories
Chantecaille Beaute Inc
- purelax
CVS Pharmacy
- Drug label
- Maximum Strength Nighttime Cold and Flu
THE KROGER CO
- Drug label
- Hydrogen Peroxide
AmerisourceBergen (Good Neighbor Pharmacy) 46122
- Sumatriptan
Preferred Pharmaceuticals Inc.
- Drug label
- Drug label
Showing 12 of 150. 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.