FDA daily for Wednesday, September 2, 2026
In this issue: 15 shortage updates, 6 approvals, 19 drug recalls, 19 device recalls, 18 device decisions, 159 label changes and 25 food or supplement recalls. 5 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.
- ZEPBOUND, ZEPBOUND KWIKPEN, ZEPBOUND (AUTOINJECTOR)
ELI LILLY AND CO · TIRZEPATIDE
- Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fre…
Fresenius Kabi USA, LLC · Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
- Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-0…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL M…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Lip Balm SPF 15
AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE · Skin Script, LLC · TOPICAL
Drug shortages
FDA date:FDA updated 15 shortage entries on Tue, Sep 1: 4 new, 4 to be discontinued, 7 status updates.
- Insulin Glargine-aglr Injection
Eli Lilly and Co.
- Glycerol Phenylbutyrate Oral Liquid
Amgen Inc.
- Insulin Lispro Protamine and Insulin Lispro Injection
Eli Lilly and Co.
- Insulin Lispro Injection
Eli Lilly and Co.
- Flurazepam Hydrochloride Capsule
Rising Pharma Holdings, Inc. · Unavailable · Reason: Regulatory delay
- Midazolam Hydrochloride Injection
Avet Pharmaceuticals, Inc. · Available
- Midazolam Hydrochloride Injection
WG Critical Care · Available
- Atropine Sulfate Injection
Accord Healthcare Inc. · Unavailable · Reason: Requirements related to complying with good manufacturing practices
- Furosemide Injection
Avet Pharmaceuticals, Inc. · Unavailable · Reason: Other
- Quinapril Hydrochloride Tablet
Lupin Pharmaceuticals, Inc. · Unavailable · Reason: Requirements related to complying with good manufacturing practices
- Cromolyn Sodium Concentrate
Rising Pharma Holdings, Inc. · Available
- Rifampin Capsule
Lupin Pharmaceuticals, Inc. · Available
- Echothiophate Iodide Ophthalmic Solution
Fera Pharmaceuticals · Available · Reason: Other
- Carboplatin Injection
Avyxa Pharma, LLC · Available
- Atropine Sulfate Injection
Fresenius Kabi USA, LLC · Available
Drug and biologic approvals
FDA date:On Wed, Aug 26 FDA approved 3 new applications (2 brand or biologic, 1 generic) and 3 supplements to existing ones.
- EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE
NATCO · EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE
- VOBRIG
SUN PHARM · LEUPROLIDE ACETATE
- RASONQUE
REVOLUTION MEDICINES · DARAXONRASIB
- ZEPBOUND, ZEPBOUND KWIKPEN, ZEPBOUND (AUTOINJECTOR)
ELI LILLY AND CO · TIRZEPATIDE
Drug recalls
FDA date:FDA's enforcement report dated Wed, Aug 26 lists 19 drug recalls: 2 Class I, 17 Class II.
- Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fre…
Fresenius Kabi USA, LLC · Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
- Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-0…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL M…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Via…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
- Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, M…
Golden State Medical Supply Inc. · CGMP deviations: tablets with black specks.
- Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 m…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmeda…
Shilpa Medicare Limited · Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactur…
Regeneron Pharmaceuticals Inc · Lack of Assurance of Sterility
- Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Device recalls
FDA date:FDA posted 19 device recalls from 7 firms on Wed, Aug 26.
- Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Fresenius Medical Care Renal Therapies Group, LLC · Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T Blu…
- CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 me…
ConMed Corporation · Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
- Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer
- Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPE…
Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer
- Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S
Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer
- Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ896…
Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer
- Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer
- Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3)…
Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer
- Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D…
Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer
- Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION…
Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer
- Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYST…
Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer
- Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ9…
Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer
Device clearances and approvals
FDA date:FDA decided 14 510(k)s and 4 PMA decisions on Wed, Aug 19.
- Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
Shokz Health Global Limited · Ear, Nose, Throat
- Swoop® Portable MR Imaging® System
Hyperfine, Inc. · Radiology
- Pascall Sensor Unit (PSU1)
Pascall Systems, Inc. · Neurology
- Elecsys Phospho-Tau (217P) Plasma
Roche Diagnostics · Immunology
- Nipro Dry Acid Concentrate Mixer
Nipro Technical Solutions, Incoporated · Gastroenterology, Urology
- ENDOFLATOR+; Smart Smoke Evacuation
Karl Storz SE & CO. KG · Obstetrics/Gynecology
- Diode Laser Therapy Systems (DL612A)
Hebei Zollvan Medical Technology Co., Ltd. · General, Plastic Surgery
- ZEROS Dental Implant System
Zeros Co., Ltd. · Dental
- PrecivityAD2 Test
C2N Diagnostics, LLC · Immunology
- ECHOLASER X4
Elesta S.P.A · General, Plastic Surgery
- EXTRON 3;EXTRON 6
DRTECH Corporation · Radiology
- Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)
CooperSurgical, Inc. · Obstetrics/Gynecology
- Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US)
Vitestro · General Hospital
- Versalock Sterile Plating System
GM Dos Reis Industria e Comercio Ltda. · Orthopedic
Label updates
FDA date:159 drug labels took effect on Wed, Aug 19; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Lip Balm SPF 15
AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE · Skin Script, LLC · TOPICAL
- GLATIRAMER ACETATE
GLATIRAMER ACETATE · Zydus Pharmaceuticals USA Inc. · SUBCUTANEOUS
- Chlorpromazine
CHLORPROMAZINE · REMEDYREPACK INC. · ORAL
Food and supplement recalls
FDA date:FDA's enforcement report dated Wed, Aug 26 lists 25 food or supplement recalls: 18 Class I, 4 Class II, 3 Class III.
- Whole Foods Medium Pico de Gallo Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and…
WFM Purchasing, LP · Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
- Organic Whole Mixed Berries, Net Wt. 48 oz (3Lb) plastic bag. packed in 6 bags per case of 10 oz each. Keep Frozen. UPC 41415-12153
Publix Super Markets, Inc. · Due to potential E. coli O145:H28 contamination
- Whole Foods Spicy Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished pro…
WFM Purchasing, LP · Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
- Whole Foods Pomegranate Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finish…
WFM Purchasing, LP · Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
- Organic Whole Mixed Berries, Net Wt. 10 oz (284 g) plastic bags, packed in 8 bags per case of 10 oz each. Keep Frozen. UPC 41415-06753
Publix Super Markets, Inc. · Due to potential E. coli O145:H28 contamination
- Organic Whole Blueberries, Net Wt 10 oz (284g) plastic bag, packed in 8 bags per case of 10 oz each. Keep Frozen UPC 41415-06453
Publix Super Markets, Inc. · Due to potential E. coli O145:H28 contamination
- Dairyland Produce, LLC Pepper Jalapeno, repackaged into the following sized clear plastic bags: 1. 1 lb., item number 01213, UPC 0009907729…
Dairyland Produce, LLC · Jalapenos may be contaminated with Salmonella.
- Whole Foods Mild Guacamole Dip No Tomatoes, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a f…
WFM Purchasing, LP · Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
- Organic Whole Blueberries, Net Wt. 48 oz (3Lb) plastic bag, packed in 6 bags per case of 10 oz each. Keep Frozen. UPC 41415-12053
Publix Super Markets, Inc. · Due to potential E. coli O145:H28 contamination
- Whole Foods Spicy Guacamole Dip No Tomatoes, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a…
WFM Purchasing, LP · Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
- Whole Foods Roasted Corn Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finis…
WFM Purchasing, LP · Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
- Whole Foods Mild Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished prod…
WFM Purchasing, LP · Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
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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