FDA daily for Wednesday, September 9, 2026
In this issue: 3 shortage updates, 14 approvals, 20 drug recalls, 9 device recalls, 21 device decisions, 162 label changes and 22 food or supplement recalls. 3 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.
- THALOMID
BRISTOL-MYERS · THALIDOMIDE
- Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL Oral Syringes, Berry Flavor/Alcohol Free, Mfg By: MCN…
Safecor Health, LLC · Cross Contamination with Other Products
- Hero Force Shield Superlight Sunscreen SPF 30
ZINC OXIDE · Church & Dwight Co., Inc. · TOPICAL
Drug shortages
FDA date:FDA updated 3 shortage entries on Tue, Sep 8: 3 status updates.
- Ifosfamide Injection
SteriMax, Inc. · Available
- Dexmedetomidine Hydrochloride Injection
Jiangsu Hengrui Pharmaceuticals Co. (US Agent eVenus Pharmaceutical Laboratories, Inc.) · Available
- Dexmedetomidine Hydrochloride Injection
Pfizer Inc. · Available
Drug and biologic approvals
FDA date:On Wed, Sep 2 FDA approved 3 new applications (0 brand or biologic, 3 generic) and 11 supplements to existing ones.
- POMALIDOMIDE
MSN · POMALIDOMIDE
- SACUBITRIL AND VALSARTAN
AUROBINDO PHARMA LTD · SACUBITRIL, VALSARTAN
- ALENDRONATE SODIUM
PRECISION DOSE INC · ALENDRONATE SODIUM
- THALOMID
BRISTOL-MYERS · THALIDOMIDE
Drug recalls
FDA date:FDA's enforcement report dated Wed, Sep 2 lists 20 drug recalls: 2 Class I, 17 Class II.
- Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL Oral Syringes, Berry Flavor/Alcohol Free, Mfg By: MCN…
Safecor Health, LLC · Cross Contamination with Other Products
- Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Il…
Fresenius Kabi USA, LLC · Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
- Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-77…
B BRAUN MEDICAL INC · Presence of Particulate matter.
- 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 1672…
ACCORD HEALTHCARE, INC. · Subpotent Drug
- 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, Manuf…
Hikma Pharmaceuticals USA INC. · Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
- Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27…
ACCORD HEALTHCARE, INC. · Subpotent Drug
- Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC…
ACCORD HEALTHCARE, INC. · Subpotent Drug
- Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
ACCORD HEALTHCARE, INC. · Subpotent Drug
- 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-…
ACCORD HEALTHCARE, INC. · Subpotent Drug
- Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States,…
Lupin Pharmaceuticals Inc. · Failed content uniformity specifications.
- Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2761…
ACCORD HEALTHCARE, INC. · Subpotent Drug
- Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
ACCORD HEALTHCARE, INC. · Subpotent Drug
Device recalls
FDA date:FDA posted 9 device recalls from 4 firms on Wed, Sep 2.
- 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)
Boston Scientific Corporation · There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed not…
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
Boston Scientific Corporation · There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed not…
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
Boston Scientific Corporation · There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed not…
- 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Fresenius Medical Care Renal Therapies Group, LLC · 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 b…
- 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Fresenius Medical Care Renal Therapies Group, LLC · 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 b…
- 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Fresenius Medical Care Renal Therapies Group, LLC · 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 b…
- 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Fresenius Medical Care Renal Therapies Group, LLC · 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 b…
- Velys Enabling Tech Robotic-Assist Station REF: 451611001
Medos International Sarl · Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
- Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025
B Braun Medical Inc · Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
Device clearances and approvals
FDA date:FDA decided 12 510(k)s and 9 PMA decisions on Wed, Aug 26.
- HOPKINS Telescopes for Arthroscopy
Karl Storz SE & CO. KG · Orthopedic
- StimTrial Neuromodulation System
Bioventus, LLC · Neurology
- Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
JOYTECH Healthcare Co., Ltd. · Cardiovascular
- OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor
Sony Corporation · Gastroenterology, Urology
- GraftGun Universal Graft Delivery System (GDS®)
SurGenTec, LLC · General Hospital
- Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns
Principle & Will Co., Ltd. · General, Plastic Surgery
- Ponto 5 Mini; Ponto 5 Superpower
Oticon Medical AB · Ear, Nose, Throat
- Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)
Maquet Critical Care AB · Gastroenterology, Urology
- Heartvue.Proton
Heartvue.ai, Inc. · Radiology
- LithoVue Elite Digital Flexible Ureteroscope System
Boston Scientific Corporation · Gastroenterology, Urology
- VariLift-C Cervical Interbody Fusion System
Wenzel Spine, Inc. · Orthopedic
- MRIA Radiation Therapy Information System (MRIA)
Manteia Technologies Co., Ltd. · Radiology
Label updates
FDA date:162 drug labels took effect on Wed, Aug 26; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Hero Force Shield Superlight Sunscreen SPF 30
ZINC OXIDE · Church & Dwight Co., Inc. · TOPICAL
- Ciprofloxacin Hydrochloride
CIPROFLOXACIN HYDROCHLORIDE · PD-Rx Pharmaceuticals, Inc. · ORAL
- Ibuprofen
IBUPROFEN · REMEDYREPACK INC. · ORAL
- Chlorpromazine hydrochloride
CHLORPROMAZINE HYDROCHLORIDE · Northstar Rx LLC · ORAL
Food and supplement recalls
FDA date:FDA's enforcement report dated Wed, Sep 2 lists 22 food or supplement recalls: 7 Class I, 15 Class II.
- Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which cont…
H & U Inc. dba Sun Noodle · 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 spec…
- Glutinous Rice Balls with Black Sesame Filling NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000053
KHONG GUAN (HQ) · Undeclared peanuts.
- Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement
ZMB Enterprises · The product contains 1,4-DMAA, Phenylethylamine and Phenibut.
- BLACK AND WHITE GLUTINOUS RICE BALLS WITH BLACK SESAME FILLING NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000084
KHONG GUAN (HQ) · Undeclared peanuts.
- Jalapeno Ranch, packed in 16 oz. glass jars, 6 jars per case, with UPC #199284564923.
Jaime's Foods ATX, LLC · Undeclared Egg Allergen
- Sirna & Sons Produce PEPPER JALAPENO BREAK 1LB, repackaged into 1 lb. plastic bags, Product Number: 55255, Packed by Sirna & Sons Produce 7…
Sirna and Sons Produce, Inc · Potential Salmonella Javiana contamination
- bettergoods brand Pistachio Nut Butter, NET WT 6.7oz (190g), UPC 194346207961
Botticelli Foods, LLC · Product may be contaminated with Salmonella.
- 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…
Byron White Formulas, Inc. · Label does not declare walnuts in English
- Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer cartons; individual fruit bars in plastic w…
Dreyer's Grand Ice Cream Inc. · Foreign object: products may contain glass pieces
- Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit bars in plastic wrap…
Dreyer's Grand Ice Cream Inc. · Foreign object: products may contain glass pieces
- Marketside Tomato Bisque Soup Kit, Tomato Bisque with Cheese Croutons & White Cheddar Cheese, Ready to Heat, Net Wt. 14 OZ (397g), with UPC…
CUISINE, KETTLE · Product had a presumptive positive test result for Listeria monocytogenes
- Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual fruit bars in plastic…
Dreyer's Grand Ice Cream Inc. · Foreign object: products may contain glass pieces
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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