FDA daily for Wednesday, September 9, 2026
281 FDA records across 7 sections. 12 touch MedGrid's categories and are listed first.
Drug shortagesCovers FDA's Tue, Sep 8 (yesterday)3
- Dexmedetomidine Hydrochloride Injection
Precedex, Injection, 80 mcg/20 mL (4 mcg/mL) (NDC 0409-3301-10) — Pfizer Inc.
- Ifosfamide Injection
Ifosfamide, Injection, 1 g/1 (NDC 21586-211-02) — SteriMax, Inc.
- Dexmedetomidine Hydrochloride Injection
Precedex, Injection, 200 mcg/2 mL (100 mcg/mL) (NDC 0409-1638-02) — Pfizer Inc.
Drug approvalsCovers FDA's Wed, Sep 2 (a week ago)14
- DIVALPROEX SODIUM
DIVALPROEX SODIUM — PHARMOBEDIENT
- BUPROPION HYDROCHLORIDE
BUPROPION HYDROCHLORIDE — ACTAVIS LABS FL INC
- POMALIDOMIDE
POMALIDOMIDE — MSN
- AVTOZMA
TOCILIZUMAB-ANOH — CELLTRION INC
- CIBINQO
ABROCITINIB — PFIZER
- AVTOZMA
TOCILIZUMAB-ANOH — CELLTRION INC
- THALOMID
THALIDOMIDE — BRISTOL-MYERS
- ETOPOPHOS PRESERVATIVE FREE
ETOPOSIDE PHOSPHATE — CHEPLAPHARM
- DAPAGLIFLOZIN
DAPAGLIFLOZIN — AJANTA PHARMA LTD
- SACUBITRIL AND VALSARTAN
SACUBITRIL, VALSARTAN — AUROBINDO PHARMA LTD
- THALIDOMIDE
THALIDOMIDE — NATCO
- FYARRO
SIROLIMUS — AADI
Showing 12 of 14. Search the rest in openFDA.
Drug recallsCovers FDA's Wed, Sep 2 (a week ago)19
- ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc… — Subpotent Drug
- Hikma Pharmaceuticals USA INC.
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33… — Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
- ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Ro… — Subpotent Drug
- ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp… — Subpotent Drug
- ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp R… — Subpotent Drug
- ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc.,… — Subpotent Drug
- Lupin Pharmaceuticals Inc.
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, IND… — Failed content uniformity specifications.
- ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road… — Subpotent Drug
- ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp R… — Subpotent Drug
- Mallinckrodt Hospital Products Inc.
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2 — Presence of particulate matter: glass and stopper piece
- ACCORD HEALTHCARE, INC.
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp R… — Subpotent Drug
- Church & Dwight Co., Inc.
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 7322… — CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Showing 12 of 19. Search the rest in openFDA.
Food and supplement recallsCovers FDA's Wed, Sep 2 (a week ago)22
- H & U Inc. dba Sun Noodle
Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup packet. Item #05410 retail packag… — Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared on finished product label.
- KHONG GUAN (HQ)
Glutinous Rice Balls with Black Sesame Filling NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000053 — Undeclared peanuts.
- Byron White Formulas, Inc.
Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404 — Label does not declare walnuts in English
- Dreyer's Grand Ice Cream Inc.
Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder. — Foreign object: products may contain glass pieces
- Dreyer's Grand Ice Cream Inc.
Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder. — Foreign object: products may contain glass pieces
- ZMB Enterprises
Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement — The product contains 1,4-DMAA, Phenylethylamine and Phenibut.
- CUISINE, KETTLE
Marketside Tomato Bisque Soup Kit, Tomato Bisque with Cheese Croutons & White Cheddar Cheese, Ready to Heat, Net Wt. 14 OZ (397g), with UPC 1 94346474004. Must Keep Refrigerated. — Product had a presumptive positive test result for Listeria monocytogenes
- Dreyer's Grand Ice Cream Inc.
Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder. — Foreign object: products may contain glass pieces
- Lidl US TRADING
ERIDANOUS GREEK STYLE Shortbread Cookies with apricot filling and cocoa topping with coconut sprinkles. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (weight), UPC: 4056… — The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).
- Dreyer's Grand Ice Cream Inc.
Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder. — Foreign object: products may contain glass pieces
- Lidl US TRADING
ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (weight), UPC: 4056489125839. — The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).
- Horizon Organic Dairy, LLC
Horizon Organic ORG ASEP CHOC MILK 1% 8OZ 12 CT (Item 136990, UPC 742365002700) and 18 CT (Item 136917, UPC 742365208867). Tetra Pak Carton. Distributed by: Horizon Organic Dairy, LLC ( Horizon ) 123… — Product has the potential to be spoiled.
Showing 12 of 22. Search the rest in openFDA.
Device recallsCovers FDA's Wed, Sep 2 (a week ago)4 touch MedGrid50
- Medline Industries, LPTouches MedGrid categories
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medl… — Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
- Medline Industries, LPTouches MedGrid categories
Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit SKU DYNJ32770V; 3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D; 4) NEURO PACK-LF, Me… — Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
- Medline Industries, LPTouches MedGrid categories
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID… — Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
- Medline Industries, LPTouches MedGrid categories
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRAN… — Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
- Medline Industries, LP
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOT… — Kits contain a potentially contaminated component which were recalled by the manufacturer
- Medline Industries, LP
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) U… — Kits contain a potentially contaminated component which were recalled by the manufacturer
- Medline Industries, LP
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPAROSC… — Kits contain a potentially contaminated component which were recalled by the manufacturer
- IMRIS Imaging Inc
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000 — The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patie…
- Medline Industries, LP
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL… — Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of locali…
- IMRIS Imaging Inc
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600 — The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patie…
- Medline Industries, LP
Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014. — Kits contain a potentially contaminated component which were recalled by the manufacturer
- Olympus Corporation of the Americas
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories — Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Showing 12 of 50. Search the rest in openFDA.
Device clearancesCovers FDA's Wed, Aug 26 (two weeks ago)12
- Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); E…
Maquet Critical Care AB
- LithoVue Elite Digital Flexible Ureteroscope System
Boston Scientific Corporation
- MRIA Radiation Therapy Information System (MRIA)
Manteia Technologies Co., Ltd.
- HOPKINS Telescopes for Arthroscopy
Karl Storz SE & CO. KG
- Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, D…
JOYTECH Healthcare Co., Ltd.
- Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AM…
Principle & Will Co., Ltd.
- StimTrial Neuromodulation System
Bioventus, LLC
- VariLift-C Cervical Interbody Fusion System
Wenzel Spine, Inc.
- Heartvue.Proton
Heartvue.ai, Inc.
- OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor
Sony Corporation
- GraftGun Universal Graft Delivery System (GDS®)
SurGenTec, LLC
- Ponto 5 Mini; Ponto 5 Superpower
Oticon Medical AB
Label changesCovers FDA's Wed, Aug 26 (two weeks ago)8 touch MedGrid161
- Lidocaine Pain ReliefTouches MedGrid categories
Cardinal Health, 110 dba LEADER
- Careland Lidocaine Plus Menthol Pain RelievingTouches MedGrid categories
Planet (Anhui) Pharmaceutical Co., Ltd
- Hero Force Shield Superlight Sunscreen SPF 30Touches MedGrid categories
Church & Dwight Co., Inc.
- Lidocaine Patch 4%Touches MedGrid categories
Global America Group LLC
- CVS Pain Relief Lidocaine XLTouches MedGrid categories
CVS Pharmacy
- CVS Pain ReliefTouches MedGrid categories
CVS Pharmacy
- MELAO Hydrating Lightweight SunscreenTouches MedGrid categories
Guangdong Aimu Biological Technology Co., Ltd
- LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) CreamTouches MedGrid categories
Guangzhou Hechuang Commercial Service Co.,Ltd.
- DOXYCYCLINE HYCLATE
NuCare Pharmaceuticals,Inc.
- anti diarrheal and anti gas
CVS Pharmacy
- Drug label
- Propranolol Hydrochloride
Par Health USA, LLC
Showing 12 of 161. 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.