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FDA Daily

FDA daily for Wednesday, September 30, 2026

200 FDA records across 7 sections. 5 touch MedGrid's categories and are listed first.

200FDA Records
7 of 7Sections With Data
5Touch MedGrid Categories

Sections in This Issue

Drug shortagesCovers FDA's Tue, Sep 29 (yesterday)
2
  • Azacitidine Injection

    Azacitidine, Injection, 100 mg (NDC 43598-305-62) — Dr. Reddy's Laboratories, Inc.

    Reverified · Current · Oncology

  • Ivermectin Tablet

    STROMECTOL, Tablet, 3 mg (NDC 0006-0032-01) — Merck Sharp & Dohme LLC

    New · To Be Discontinued · Anti-Infective

Drug approvalsCovers FDA's Wed, Sep 23 (a week ago)
1 touch MedGrid19
  • NORGESTIMATE AND ETHINYL ESTRADIOLTouches MedGrid categories

    ETHINYL ESTRADIOL, NORGESTIMATE — ANNORA PHARMA

    ANDA220876 · Original approval

  • PAXIL

    PAROXETINE HYDROCHLORIDE — APOTEX

    NDA020710 · Labeling

  • DIVALPROEX SODIUM

    DIVALPROEX SODIUM — IMPAX LABS

    ANDA078791 · Labeling

  • SPIRONOLACTONE

    SPIRONOLACTONE — MYLAN

    ANDA040424 · Labeling

  • MEXILETINE HYDROCHLORIDE

    MEXILETINE HYDROCHLORIDE — ZYDUS PHARMS

    ANDA214598 · Original approval

  • ONSWIK

    INSULIN EFSITORA ALFA-GOBE — ELI LILLY AND CO

    BLA761408 · Original approval

  • TYVASO DPI

    TREPROSTINIL — UNITED THERAP

    NDA214324 · Labeling

  • CLAFORAN

    CEFOTAXIME SODIUM — STERIMAX

    NDA050547 · Labeling

  • CRESTOR

    ROSUVASTATIN CALCIUM — ASTRAZENECA

    NDA021366 · Labeling

  • TEPEZZA

    TEPROTUMUMAB-TRBW — HORIZON THERAPEUTICS IRELAND

    BLA761143 · Labeling

  • ATOVAQUONE

    ATOVAQUONE — APOTEX

    ANDA209750 · Labeling

  • HALOPERIDOL DECANOATE

    HALOPERIDOL DECANOATE — GLAND

    ANDA205241 · Labeling

Showing 12 of 19. Search the rest in openFDA.

Drug recallsCovers FDA's Wed, Sep 23 (a week ago)
1 touch MedGrid11
  • SUN PHARMA /TAROTouches MedGrid categories

    Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC… — Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

    Class II · NY · Ongoing

  • Safecor Health, LLC

    Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04 — Failed Stability Specifications

    Class II · MA · Ongoing

  • Safecor Health, LLC

    Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04 — Failed Stability Specifications

    Class II · MA · Ongoing

  • Safecor Health, LLC

    Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04 — Failed Stability Specifications

    Class II · MA · Ongoing

  • VITRUVIAS THERAPEUTICS INC

    Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by: Vitruvias Therapeutics, Auburn, AL 36830, Pr… — Superpotent Drug

    Class I · AL · Ongoing

  • Safecor Health, LLC

    Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16 — Failed Stability Specifications

    Class II · MA · Ongoing

  • Safecor Health, LLC

    Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04 — Failed Stability Specifications

    Class II · MA · Ongoing

  • Safecor Health, LLC

    Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16 — Failed Stability Specifications

    Class II · MA · Ongoing

  • Inventia Healthcare Limited

    Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01 — Failed Dissolution Specifications

    Class II · N/A · Ongoing

  • SUN PHARMACEUTICAL INDUSTRIES INC

    Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-1289… — Failed Stability Specifications

    Not Yet Classified · NJ · Ongoing

  • Pfizer

    Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01. — Lack of Assurance of Sterility

    Class II · NY · Ongoing

Food and supplement recallsCovers FDA's Wed, Sep 23 (a week ago)
1 touch MedGrid49
  • Buckhead Meat Company D.B.A. Trinity SeafoodTouches MedGrid categories

    Buckhead, Tuna, 10lb cs, 12lb cs, 15lb cs, 3-5lb cs , Styrofoam container, Keep Refrigerated — The Firm was notified by NJ Department of Health of two samples collected from tuna with reported high levels of scombrotoxin.

    Class II · NJ · Ongoing

  • Everything Sprouts, LLC

    Everything Sprouts Crunchy Protein Sprout Mix, containing Alfalfa Fenugreek, Cabbage, Mung, Adzuki, Lentils, Green Pea, Net Wt. 5.0 oz (142 g) UPC 0 87906-01018 7. everythingsprouts.com — Sprouts may be contaminated with STEC E. coli and/or Salmonella.

    Class I · MN · Ongoing

  • Taylor Fresh Foods Inc

    Tomato Salsa Fresca. Ingredients: Tomatoes, Yellow Onion, Red Onion, Cilantro, Jalapeno Pepper, Garlic, Salt, Ground Cumin, Lemon Juice. Net Wt: 4 lbs. Keep Refrigerated. — Potential contamination with Salmonella.

    Class I · CA · Ongoing

  • NatureBest Pre-Cut & Produce LLc

    PICO DE GALLO-HOT-6/9oz HEB-PICO-HOT-12/14oz — Jalapenos have the potential to be contaminated with Salmonella

    Class I · TX · Ongoing

  • Tiffany Food Corp

    Hexing Haw Balls candy; packaged in 200g/0.44 lb./7.05 oz clear plastic bag; Ingredients: haw, white sugar, water.; Serving suggestion: ready to eat. Storage: keep in cool and dry place and keep tigh… — Unapproved dye Ponceau 4R

    Class III · NY · Ongoing

  • Taylor Fresh Foods Inc

    Pico De Gallo. Ingredients: Tomato, Onion, Jalapeno Pepper, Cilantro, Garlic, Salt, Black Pepper. Net Wt: 7 oz. Keep Refrigerated. Distributed By: ADUSA Distribution, LLC, Salisbury, NC 28147. UPC: 6… — Potential contamination with Salmonella.

    Class I · CA · Ongoing

  • Taylor Fresh Foods Inc

    Pineapple Mango Salsa Mild. Ingredients: Mango, Pineapple, Pasteurized Lime Juice, Pasteurized Lemon Juice, Jalapeno Pepper, Serrano Pepper, Lime Flavored Zest (***), Lemon Peel (***), Spearmint, Sal… — Potential contamination with Salmonella.

    Class I · CA · Ongoing

  • NatureBest Pre-Cut & Produce LLc

    HEB-PICO-MEDIUM-12/14oz PICO DE GALLO-MEDIUM-6/14oz PICO DE GALLO-MEDIUM-6/9oz PICO-DE-GALLO-MEDIUM-BGC-1/5# PICO-MEDIUM-SNACK-12/4oz — Jalapenos have the potential to be contaminated with Salmonella

    Class I · TX · Ongoing

  • Taylor Fresh Foods Inc

    Spicy Guacamole. Ingredients: Guacamole, Pico De Gallo. Spec Sheet: Guacamole (Avocado, Pico De Gallo, Serrano Peper, Lime Juice, Salt, Pepper); Pico De Gallo (Cilantro, Jalapeno Pepper, Tomato, Yell… — Potential contamination with Salmonella.

    Class I · CA · Ongoing

  • Panorama Produce Sales Inc.

    Martina brand Fresh Whole Mangoes; Individual whole mangoes, variable weight; 9 mangoes per carton box — Product may be contaminated with Salmonella

    Class II · NY · Ongoing

  • Taylor Fresh Foods Inc

    Taco Dip. Ingredients: Refried Vegetarian Beans *** Guacamole (***Pico De Gallo [***Jalapeno Pepper]***), Pico De Gallo (***Jalapeno Pepper), Mild Cheddar Cheese *** Sour Cream *** Black Ripe Olives… — Potential contamination with Salmonella.

    Class I · CA · Ongoing

  • Taylor Fresh Foods Inc

    Pico De Gallo. Ingredients: Tomato, Onion, Jalapeno, Cilantro. Net Wt: 16 oz. Keep Refrigerated. Distributed By: Taylor Farms Inc., Salinas, CA 93902. UPC: 030223073536 — Potential contamination with Salmonella.

    Class I · CA · Ongoing

Showing 12 of 49. Search the rest in openFDA.

Device recallsCovers FDA's Wed, Sep 23 (a week ago)
88
  • Stryker Sustainability Solutions

    REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM — Reusable access port system may crack or seperate during use.

    Class II · AZ · Ongoing

  • Datex-Ohmeda, Inc.

    Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000 — Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling…

    Class II · WI · Ongoing

  • Datex-Ohmeda, Inc.

    Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665 — Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling…

    Class II · WI · Ongoing

  • AVID Medical, Inc.

    Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02; — Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

    Class I · VA · Ongoing

  • Medline Industries, LP

    Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A — The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin…

    Class I · IL · Ongoing

  • GE Medical Systems Information Technologies Inc

    Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV — Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.

    Class II · WI · Ongoing

  • Nova Biomedical Corporation

    StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. — A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) ba…

    Class I · MA · Ongoing

  • ICU Medical, Inc.

    Oncology sets with drip chambers — Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not…

    Class II · CA · Ongoing

  • Datex-Ohmeda, Inc.

    Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000 — Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling…

    Class II · WI · Ongoing

  • ICU Medical, Inc.

    Oncology sets with drip chambers — Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not…

    Class II · CA · Ongoing

  • Medline Industries, LP

    Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N — The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior…

    Class II · IL · Ongoing

  • ICU Medical, Inc.

    IV Sets with drip chambers — Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence…

    Class II · CA · Ongoing

Showing 12 of 88. Search the rest in openFDA.

Device clearancesCovers FDA's Wed, Sep 16 (two weeks ago)
2 touch MedGrid24
  • AerFrame™ Alignment Laser Box (LBV2)Touches MedGrid categories

    Stabilix, LLC

    K261865 · Substantially Equivalent · Radiology

  • SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Ac…Touches MedGrid categories

    Olympus Surgical Technologies America

    K262877 · Substantially Equivalent · General, Plastic Surgery

  • JADE SCORE PTA Scoring Balloon Dilatation Catheter

    OrbusNeich Medical (Shenzhen) Co., Ltd.

    K261778 · Substantially Equivalent · Cardiovascular

  • Embrace Vision Neonatal MRI System

    Aspect Imaging, Ltd.

    K261758 · Substantially Equivalent · Radiology

  • Mouth Guard

    ChangSha ChuangDuoLe E-Commerce Co., Ltd.

    K262559 · Substantially Equivalent · Unknown

  • EchoPAC Software Only / EchoPAC Plug-in (v211)

    GE Medical Systems Ultrasound and Primary Care Diagnostics

    K261623 · Substantially Equivalent · Radiology

  • ElintMAX Respiratory Monitor (ElintMAX Monitor A1)

    Amptron Medical, Inc.

    K260226 · Substantially Equivalent · Anesthesiology

  • Route 92 Medical Full Length 046 Access System

    Route 92 Medical, Inc.

    K260220 · Substantially Equivalent · Cardiovascular

  • Aristotle 65 Macrowire

    Scientia Vascular

    K254181 · Substantially Equivalent · Cardiovascular

  • Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set

    Ambu A/S

    K260309 · Substantially Equivalent · Ear, Nose, Throat

  • Multifunctional wheelchair (YJ-059)

    Zhenjiang Assure Medical Equipment Co., Ltd.

    K261919 · Substantially Equivalent · Physical Medicine

  • Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large

    Ambu A/S

    K261400 · Substantially Equivalent · Gastroenterology, Urology

Showing 12 of 24. Search the rest in openFDA.

Label changesCovers FDA's Wed, Sep 16 (two weeks ago)
7
  • 12 hr relief cough dm

    CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

    Label version 3

  • PAROXETINE HYDROCHLORIDE

    Apotex Corp

    Label version 19

  • Drug label

    Label version 8

  • Mirtazapine

    NCS HealthCare of KY, LLC dba Vangard Labs

    Label version 1

  • Metoprolol Succinate

    REMEDYREPACK INC.

    Label version 2

  • Drug label

    Label version 2

  • Drug label

    Label version 6

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.