FDA daily for Wednesday, October 14, 2026
In this issue: 4 shortage updates, 21 approvals, 9 drug recalls, 28 device recalls, 20 device decisions, 4 label changes and 14 food or supplement recalls. 2 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.
- Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deer…
TerSera Therapeutics LLC · Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
- Organiccs Absolutely Pure, Type-1 Hydrolyzed Collagen Peptides, All-Natural Aid for Strengthening Hair, Skin, Nails, Muscles & Joints, 180…
Pacific Health Sciences Llc · Undeclared shellfish (crab shell): source of ingredient Glucosamine sulfate
Drug shortages
FDA date:FDA updated 4 shortage entries on Tue, Oct 13: 4 status updates.
- Rifampin Capsule
Lupin Pharmaceuticals, Inc. · Available
- Quinapril Hydrochloride Tablet
Lupin Pharmaceuticals, Inc. · Unavailable · Reason: Requirements related to complying with good manufacturing practices
- Hydroxocobalamin Injection
Teva Pharmaceuticals USA, Inc. · Unavailable · Reason: Other
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Granules Pharmaceuticals Inc. · Unavailable · Reason: Shortage of an active ingredient
Drug and biologic approvals
FDA date:On Wed, Oct 7 FDA approved 3 new applications (0 brand or biologic, 3 generic) and 18 supplements to existing ones.
- MIRABEGRON
CREEKWOOD PHARMS · MIRABEGRON
- FIDAXOMICIN
HIKMA · FIDAXOMICIN
- HYDROCHLOROTHIAZIDE
RUBICON RESEARCH · HYDROCHLOROTHIAZIDE
Drug recalls
FDA date:FDA's enforcement report dated Wed, Oct 7 lists 9 drug recalls: 8 Class II.
- Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deer…
TerSera Therapeutics LLC · Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
- Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles (NDC 0536-1351…
SV Labs Toronto Corporation · Microbial contamination of topical product.
- Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-…
Amneal Pharmaceuticals, LLC · Defective Container; packets were found to be either empty or partially full.
- FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. ND…
Aurolab Trust · Lack of Assurance of Sterility
- Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manu…
Apotex Corp. · Failed dissolution specifications.
- Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48…
SV Labs Toronto Corporation · Microbial contamination of topical product.
- Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-1…
Par Health USA, LLC · Crystallization
- Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27…
Ajanta Pharma USA Inc · Failed Dissolution Specifications: below specification
- amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seat…
Aurobindo Pharma USA Inc · Discoloration: consumer complaints received for discolored tablets
Device recalls
FDA date:FDA posted 28 device recalls from 7 firms on Wed, Oct 7.
- DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
AVID Medical, Inc. · Product may be potentially contaminated with a lubricant used during the manufacturing process.
- GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;
AVID Medical, Inc. · Product may be potentially contaminated with a lubricant used during the manufacturing process.
- ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;
AVID Medical, Inc. · Product may be potentially contaminated with a lubricant used during the manufacturing process.
- ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;
AVID Medical, Inc. · Product may be potentially contaminated with a lubricant used during the manufacturing process.
- CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;
AVID Medical, Inc. · Product may be potentially contaminated with a lubricant used during the manufacturing process.
- PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;
AVID Medical, Inc. · Product may be potentially contaminated with a lubricant used during the manufacturing process.
- ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
AVID Medical, Inc. · Product may be potentially contaminated with a lubricant used during the manufacturing process.
- LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;
AVID Medical, Inc. · Product may be potentially contaminated with a lubricant used during the manufacturing process.
- PLASTICS TRAY; Model/Item Number (Kit): EURO053;
AVID Medical, Inc. · Product may be potentially contaminated with a lubricant used during the manufacturing process.
- DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;
AVID Medical, Inc. · Product may be potentially contaminated with a lubricant used during the manufacturing process.
- HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
AVID Medical, Inc. · Product may be potentially contaminated with a lubricant used during the manufacturing process.
- UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;
AVID Medical, Inc. · Product may be potentially contaminated with a lubricant used during the manufacturing process.
Device clearances and approvals
FDA date:FDA decided 13 510(k)s and 7 PMA decisions on Wed, Sep 30.
- Elos Accurate Hybrid Base
Elos Medtech Pinol A/S · Dental
- Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine
Brainlab SE · Neurology
- Eonis SMA kit
Revvity, Inc. · Immunology
- EzSensor HD
Qpix Solutions, Inc. · Dental
- Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character).
Barco N.V. · Cardiovascular
- Rapid Barostat Bag (RBB) Pump and Catheter System
Mui Scientific, Inc. · Gastroenterology, Urology
- SAS MIS Pelvic Incidence Rods
Spinal Alignment Solutions, Inc. · Orthopedic
- danumed StomaMeter
Danumed Medizintechnik GmbH · Gastroenterology, Urology
- Braun Aura 7 (6041)
CyDen Limited · General, Plastic Surgery
- Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)
Fussen Technology Co., Ltd. · Radiology
- ECG Analysis Software (AiTiALVSD)
Medical AI Co., Ltd. · Cardiovascular
- Duet Spinal Fixation System
Duet Spine Holdings, LLC · Orthopedic
- CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)
Centers for Disease Control and Prevention · Microbiology
Label updates
FDA date:4 drug labels took effect on Wed, Sep 30. Below: those, and labels carrying a boxed warning.
Food and supplement recalls
FDA date:FDA's enforcement report dated Wed, Oct 7 lists 14 food or supplement recalls: 8 Class I, 6 Class II.
- Organiccs Absolutely Pure, Type-1 Hydrolyzed Collagen Peptides, All-Natural Aid for Strengthening Hair, Skin, Nails, Muscles & Joints, 180…
Pacific Health Sciences Llc · Undeclared shellfish (crab shell): source of ingredient Glucosamine sulfate
- Todd's Seeds Salad Sprouting Mixture - Broccoli, Mustard, Alfalfa and Cabbage, packaged in heat-sealed resealable bags in the following siz…
TODD'S SEEDS LLC · Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)
- Todd's Seeds Broccoli & Friends Sprouting Seed Mix - Broccoli, Alfalfa, Radish, Clover, packaged in 1 oz. sample packets and heat-sealed re…
TODD'S SEEDS LLC · Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)
- Coco G's Courmet Flaming Cheddar Hots, Spicy Cheddar Cheese Popcorn. Packaged in the following sized plastic bags: 1. 2.5 oz (81g), UPC 6 9…
Coco G's Snack Foods, Inc. · Potential Salmonella contamination.
- Salata Salad Kitchen Jalapen¿o Avocado Dressing. Keep Refrigerated. Packaged in the following sizes: 1. 12.5 fl. oz. (369 mL), UPC 8 50043-…
Salata Dressings, LLC · This recall was initiated due to potential Salmonella contamination in diced jalape¿no received from the supplier
- Todd's Seeds Variety Pack of Sprouting Seeds - Broccoli, Alfalfa, Radish Mung & Clover, packaged as a multi-pack consisting of 2 oz. heat-s…
TODD'S SEEDS LLC · Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)
- Todd's Seeds Alfalfa & Mung Bundle (1lb each), packaged separately in heat-sealed resealable bags
TODD'S SEEDS LLC · Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)
- Todd's Seeds Sprouting Seed Mix - Broccoli, Radish, Alfalfa, packaged in heat-sealed resealable bags in the following sizes: 1/4 lb., 1/2 l…
TODD'S SEEDS LLC · Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)
- Todd's Seeds Alfalfa Sprouting Seeds, packaged in heat-sealed resealable bags in the following sizes: 1/4 lb., 1/2 lb., 1 lb., 2.5 lb., and…
TODD'S SEEDS LLC · Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)
- Lior brand Cinnamon Ground Seasoning; 90g transparent plastic container; UPC 794711005484.
Galil Importing Corp · Product contains elevated levels of lead.
- Kofinas Garlic Mediterranean Infused Extra Virgin Olive Oil, packaged in 3.4 fl oz (100mL), 8.5 fl oz (250mL), and 17 fl oz (500mL) glass b…
LMSI, LLC · Product contains garlic essential oil not approved for culinary use
- 7up Tropical beverage, shelf stable, 12oz can in a 12pk wrap, labeled as 7 up Tropical Beverage containing cans that are labeled as 7Up Tro…
Admiral Beverage Corporation · Product may contain undeclared sugar.
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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