FDA daily for Wednesday, October 14, 2026
212 FDA records across 7 sections. 5 touch MedGrid's categories and are listed first.
Drug shortagesCovers FDA's Tue, Oct 13 (yesterday)15
- Rifampin Capsule
Rifampin, Capsule, 300 mg (NDC 68180-659-07) — Lupin Pharmaceuticals, Inc.
- Quinapril Hydrochloride Tablet
Quinapril Hydrochloride, Tablet, 5 mg (NDC 68180-556-09) — Lupin Pharmaceuticals, Inc.
- Quinapril Hydrochloride Tablet
Quinapril Hydrochloride, Tablet, 20 mg (NDC 68180-558-09) — Lupin Pharmaceuticals, Inc.
- Quinapril Hydrochloride Tablet
Quinapril Hydrochloride, Tablet, 10 mg (NDC 68180-557-09) — Lupin Pharmaceuticals, Inc.
- Hydroxocobalamin Injection
Hydroxocobalamin, Injection, 1000 MCG/ML, 30 ML Multi-Dose Vial (NDC 0591-2888-30) — Teva Pharmaceuticals USA, Inc.
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 70010-113-01) — Granules Pharmaceuticals Inc.
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 70010-115-01) — Granules Pharmaceuticals Inc.
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.125 mg; 3.125 mg; 3.125 mg; 3.125 mg (NDC 70010-114-01) — Granules Pharmaceuticals Inc.
- Quinapril Hydrochloride Tablet
Quinapril Hydrochloride, Tablet, 40 mg (NDC 68180-554-09) — Lupin Pharmaceuticals, Inc.
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 70010-111-01) — Granules Pharmaceuticals Inc.
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 70010-116-01) — Granules Pharmaceuticals Inc.
- Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 70010-117-01) — Granules Pharmaceuticals Inc.
Showing 12 of 15. Search the rest in openFDA.
Drug approvalsCovers FDA's Wed, Oct 7 (a week ago)21
- ABSORICA
ISOTRETINOIN — SUN PHARM INDS INC
- AMNESTEEM
ISOTRETINOIN — MYLAN PHARMS INC
- TUKYSA
TUCATINIB — SEAGEN
- ISOTRETINOIN
ISOTRETINOIN — AMNEAL PHARMS NY
- ISOTRETINOIN
ISOTRETINOIN — UPSHER SMITH LABS
- ZENATANE
ISOTRETINOIN — DR REDDYS LABS LTD
- MYORISAN
ISOTRETINOIN — UPSHER SMITH LABS
- MIRABEGRON
MIRABEGRON — CREEKWOOD PHARMS
- ISOTRETINOIN
ISOTRETINOIN — UPSHER SMITH LABS
- ISOTRETINOIN
ISOTRETINOIN — AUROBINDO PHARMA LTD
- ISOTRETINOIN
ISOTRETINOIN — ACTAVIS LABS FL
- ISOTRETINOIN
ISOTRETINOIN — AUROBINDO PHARMA
Showing 12 of 21. Search the rest in openFDA.
Drug recallsCovers FDA's Wed, Oct 7 (a week ago)1 touch MedGrid9
- Amneal Pharmaceuticals, LLCTouches MedGrid categories
Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3. — Defective Container; packets were found to be either empty or partially full.
- SV Labs Toronto Corporation
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 0536-1351-42), Distributed by: Rugby Laboratories, 17177 N. Laurel Pa… — Microbial contamination of topical product.
- Aurolab Trust
FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19 — Lack of Assurance of Sterility
- TerSera Therapeutics LLC
Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, E… — Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.
- Aurobindo Pharma USA Inc
amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, Made in India, NDC 72288-692-01. UPC 1 95515… — Discoloration: consumer complaints received for discolored tablets
- Apotex Corp.
Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505… — Failed dissolution specifications.
- SV Labs Toronto Corporation
Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63 — Microbial contamination of topical product.
- Par Health USA, LLC
Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05 — Crystallization
- Ajanta Pharma USA Inc
Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02 — Failed Dissolution Specifications: below specification
Food and supplement recallsCovers FDA's Wed, Oct 7 (a week ago)1 touch MedGrid14
- Pacific Health Sciences LlcTouches MedGrid categories
Organiccs Absolutely Pure, Type-1 Hydrolyzed Collagen Peptides, All-Natural Aid for Strengthening Hair, Skin, Nails, Muscles & Joints, 180 Veggie Capsules. UPC: none — Undeclared shellfish (crab shell): source of ingredient Glucosamine sulfate
- TODD'S SEEDS LLC
Todd's Seeds Salad Sprouting Mixture - Broccoli, Mustard, Alfalfa and Cabbage, packaged in heat-sealed resealable bags in the following sizes: 1/4 lb., 1/2 lb., and 1 lb. — Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)
- Galil Importing Corp
Lior brand Cinnamon Ground Seasoning; 90g transparent plastic container; UPC 794711005484. — Product contains elevated levels of lead.
- LMSI, LLC
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 bottles, UPC: 799475717185 (on 8.5 fl oz/250mL), 799475717178… — Product contains garlic essential oil not approved for culinary use
- Admiral Beverage Corporation
7up Tropical beverage, shelf stable, 12oz can in a 12pk wrap, labeled as 7 up Tropical Beverage containing cans that are labeled as 7Up Tropical Zero Sugar which contain full sugar soda. 12 fl oz, UP… — Product may contain undeclared sugar.
- TODD'S SEEDS LLC
Todd's Seeds Broccoli & Friends Sprouting Seed Mix - Broccoli, Alfalfa, Radish, Clover, packaged in 1 oz. sample packets and heat-sealed resealable bags in the following sizes: 1/4 lb., 1/2 lb., 1 lb… — Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)
- Coco G's Snack Foods, Inc.
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 94161-25911 9. 2. 4.15 oz (118g), UPC 6 94161-38911 3. 3. 5 o… — Potential Salmonella contamination.
- Salata Dressings, LLC
Salata Salad Kitchen Jalapen¿o Avocado Dressing. Keep Refrigerated. Packaged in the following sizes: 1. 12.5 fl. oz. (369 mL), UPC 8 50043-70646 5. 2. 1 gallon jugs, 4 per shipping case. Made by Sala… — This recall was initiated due to potential Salmonella contamination in diced jalape¿no received from the supplier
- TODD'S SEEDS LLC
Todd's Seeds Variety Pack of Sprouting Seeds - Broccoli, Alfalfa, Radish Mung & Clover, packaged as a multi-pack consisting of 2 oz. heat-sealed resealable bags each — Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)
- TODD'S SEEDS LLC
Todd's Seeds Alfalfa & Mung Bundle (1lb each), packaged separately in heat-sealed resealable bags — Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)
- SLT Foods Inc.
Khazana The Treasure Spice Magic Fennel Candy, 5 lbs., Poly Plastic Bag, 4 per case — Undeclared Yellow 5 & 6, Red 3, and Blue 1
- TODD'S SEEDS LLC
Todd's Seeds Sprouting Seed Mix - Broccoli, Radish, Alfalfa, packaged in heat-sealed resealable bags in the following sizes: 1/4 lb., 1/2 lb., 1 lb., and 5 lb. — Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall)
Showing 12 of 14. Search the rest in openFDA.
Device recallsCovers FDA's Wed, Oct 7 (a week ago)3 touch MedGrid136
- Alere San Diego, Inc.Touches MedGrid categories
Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025; Henry Schein One Step+ hCG Combo test in Se… — hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- Alere San Diego, Inc.Touches MedGrid categories
Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073; Alere hCG Cassette (25mIU/mL) in… — hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- Alere San Diego, Inc.Touches MedGrid categories
McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific Sure-Vue Serum/Urine¿hCG-STAT, Model/ Part: FH… — hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
- ASP Global, LLC.
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 Software Version: Not Applicable Product Description: Sterile Disposable T… — Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
- Medline Industries, LP
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE — Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additi…
- Philips North America
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13; — When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction…
- ASP Global, LLC.
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107001 Software Version: Not Applicable Product Description: Sterile Dis… — Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
- ASP Global, LLC.
Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 2-LINE (CS 12) ORANGE Model/Catalog Number: A70107017 Software Version: Not Applicable Product Description: S… — Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
- SPECTRUM MEDICAL SRL
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A Product Description: The Quantum PureFlow Sta… — Due to blood-to-glycol leak in the heat exchanger.
- Merit Medical Systems, Inc.
Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere 900-1200 micrometer 2 mL S… — Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.
- Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT 530 with software — Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images fro…
- Percussionaire Corporation
Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC — Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting…
Showing 12 of 136. Search the rest in openFDA.
Device clearancesCovers FDA's Wed, Sep 30 (two weeks ago)13
- Elos Accurate Hybrid Base
Elos Medtech Pinol A/S
- Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine
Brainlab SE
- Eonis SMA kit
Revvity, Inc.
- EzSensor HD
Qpix Solutions, Inc.
- Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character).
Barco N.V.
- Rapid Barostat Bag (RBB) Pump and Catheter System
Mui Scientific, Inc.
- SAS MIS Pelvic Incidence Rods
Spinal Alignment Solutions, Inc.
- danumed StomaMeter
Danumed Medizintechnik GmbH
- Braun Aura 7 (6041)
CyDen Limited
- Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)
Fussen Technology Co., Ltd.
- ECG Analysis Software (AiTiALVSD)
Medical AI Co., Ltd.
- Duet Spinal Fixation System
Duet Spine Holdings, LLC
Showing 12 of 13. Search the rest in openFDA.
Label changesCovers FDA's Wed, Sep 30 (two weeks ago)4
- Pantoprazole Sodium
Avenacy, LLC
- Drug label
- Drug label
- Drug label
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.