FDA daily for Wednesday, September 2, 2026
278 FDA records across 7 sections. 10 touch MedGrid's categories and are listed first.
Drug shortagesCovers FDA's Tue, Sep 1 (yesterday)14
- Atropine Sulfate Injection
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-525-08) — Accord Healthcare Inc.
- Flurazepam Hydrochloride Capsule
Flurazepam Hydrochloride, Capsule, 30 mg (NDC 0378-4430-01) — Rising Pharma Holdings, Inc.
- Glycerol Phenylbutyrate Oral Liquid
RAVICTI, Oral Liquid, 1.1 g/1 mL (NDC 75987-050-07) — Amgen Inc.
- Atropine Sulfate Injection
Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-512-43) — Accord Healthcare Inc.
- Echothiophate Iodide Ophthalmic Solution
Phospholine Iodide, Ophthalmic Solution, 0.125% (NDC 48102-053-05) — Fera Pharmaceuticals
- Carboplatin Injection
Kyxata, Injection, 80 mg/8 mL (10 mg/mL) (NDC 83831-141-08) — Avyxa Pharma, LLC
- Insulin Lispro Injection
Insulin Lispro Junior KwikPen, Injection, 100 [iU]/1 mL (NDC 0002-7752-05) — Eli Lilly and Co.
- Insulin Lispro Protamine and Insulin Lispro Injection
Humalog Mix 75/25, Injection, 100 [iU]/1 mL (NDC 0002-8233-05) — Eli Lilly and Co.
- Atropine Sulfate Injection
Atropine Sulfate, Injection, 1 mg/1 mL (NDC 16729-526-08) — Accord Healthcare Inc.
- Carboplatin Injection
Kyxata, Injection, 500 mg/50 mL (10 mg/mL) (NDC 83831-142-50) — Avyxa Pharma, LLC
- Flurazepam Hydrochloride Capsule
Flurazepam Hydrochloride, Capsule, 15 mg (NDC 0378-4415-01) — Rising Pharma Holdings, Inc.
- Insulin Glargine-aglr Injection
Rezvoglar, Injection, 100 [iU]/1 mL (NDC 0002-8980-05) — Eli Lilly and Co.
Showing 12 of 14. Search the rest in openFDA.
Drug approvalsCovers FDA's Wed, Aug 26 (a week ago)1 touch MedGrid6
- ZEPBOUNDTouches MedGrid categories
TIRZEPATIDE — ELI LILLY AND CO
- VOBRIG
LEUPROLIDE ACETATE — SUN PHARM
- IBUPROFEN
IBUPROFEN — GUARDIAN DRUG
- GATTEX KIT
TEDUGLUTIDE — TAKEDA PHARMS USA
- EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE
EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE — NATCO
- RASONQUE
DARAXONRASIB — REVOLUTION MEDICINES
Drug recallsCovers FDA's Wed, Aug 26 (a week ago)19
- American Regent, Inc.
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 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx O… — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Golden State Medical Supply Inc.
Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Markete… — CGMP deviations: tablets with black specks.
- American Regent, Inc.
Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx Only, AMERICAN REG… — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- American Regent, Inc.
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 INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC.… — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- American Regent, Inc.
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 Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRL… — Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
- American Regent, Inc.
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 INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC.… — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Shilpa Medicare Limited
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridg… — Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- American Regent, Inc.
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) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN… — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Regeneron Pharmaceuticals Inc
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591;… — Lack of Assurance of Sterility
- American Regent, Inc.
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 only, AMERICAN REGENT, INC., Shirley, NY 11967. — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Mylan Pharmaceuticals Inc
Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80. — Failed Dissolution Specifications
- Shilpa Medicare Limited
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridge… — Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Showing 12 of 19. Search the rest in openFDA.
Food and supplement recallsCovers FDA's Wed, Aug 26 (a week ago)25
- WFM Purchasing, LP
Whole Foods Medium Pico de Gallo Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the f… — Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
- Prospector Popcorn, LLC
Prospector Popcorn Fudge Brownie Gourmet Popcorn 1.5oz and 3.5oz — Inaccurately declared nutrients including Potassium (overstated) and Calcium (overstated).
- Publix Super Markets, Inc.
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 — Due to potential E. coli O145:H28 contamination
- WFM Purchasing, LP
Whole Foods Spicy Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Co… — Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
- Nutrient Foods, LLC
Protein Cereal Cocoa Crunch. Shelf stable, ready to eat cereal product. 25-year shelf life, metalized poly pillow pouch. Net wt.8.9 oz (252g). 1 pillow pouch per kit. Nutrient, 110 Woodland Ave Reno,… — Soy not declared in the contains statement.
- WFM Purchasing, LP
Whole Foods Pomegranate Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following… — Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
- Prospector Popcorn, LLC
Prospector Popcorn Maple Walnut Ice Cream Gourmet Popcorn 3.5 oz. — Inaccurately declared nutrients including Potassium (overstated), Calcium (overstated), and Iron (understated).
- Gifford's Dairy, Inc.
Gifford's HomeMaine ice cream brand POWER PLAY FUDGE; ONE QUART (946 mL); UPC: 8 60864 00030 7 — Potential foreign object contamination: rubber pieces
- Publix Super Markets, Inc.
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 — Due to potential E. coli O145:H28 contamination
- Prospector Popcorn, LLC
Prospector Popcorn Chocolate Mocha Gourmet Popcorn 1.5 oz. — Inaccurately declared nutrients including Carbohydrates (understated) and Cholesterol (understated).
- Prospector Popcorn, LLC
Prospector Popcorn Belgian Chocolate Toffee Gourmet Popcorn 3.5oz — Inaccurately declared nutrients including Iron (understated), and Vitamin D (overstated).
- Publix Super Markets, Inc.
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 — Due to potential E. coli O145:H28 contamination
Showing 12 of 25. Search the rest in openFDA.
Device recallsCovers FDA's Wed, Aug 26 (a week ago)2 touch MedGrid41
- American Contract Systems IncTouches MedGrid categories
American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF. — The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected varia…
- American Contract Systems IncTouches MedGrid categories
American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model I… — The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected varia…
- Intersurgical Inc
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device. — Devices could potentially be occluded or partially occluded.
- Boston Scientific Corporation
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. — Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
- AVID Medical, Inc.
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907). — The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
- Intersurgical Inc
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device. — Devices could potentially be occluded or partially occluded.
- Siemens Healthcare Diagnostics, Inc.
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL — Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, includ…
- Gentherm Medical, LLC
Blanketrol II Model 222S; Thermal regulating system. — Overheating of the 115V CPU board may cause the device to shut down.
- restor3d Inc.
Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product… — Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
- Siemens Healthcare Diagnostics, Inc.
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL — Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, includ…
- Paragonix Technologies Inc.
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001 — Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
- Tobii Dynavox Llc
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 — Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and ga…
Showing 12 of 41. Search the rest in openFDA.
Device clearancesCovers FDA's Wed, Aug 19 (two weeks ago)2 touch MedGrid14
- Diode Laser Therapy Systems (DL612A)Touches MedGrid categories
Hebei Zollvan Medical Technology Co., Ltd.
- ECHOLASER X4Touches MedGrid categories
Elesta S.P.A
- Elecsys Phospho-Tau (217P) Plasma
Roche Diagnostics
- PrecivityAD2 Test
C2N Diagnostics, LLC
- Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, S…
Shokz Health Global Limited
- ENDOFLATOR+; Smart Smoke Evacuation
Karl Storz SE & CO. KG
- Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)
CooperSurgical, Inc.
- Versalock Sterile Plating System
GM Dos Reis Industria e Comercio Ltda.
- Pascall Sensor Unit (PSU1)
Pascall Systems, Inc.
- EXTRON 3;EXTRON 6
DRTECH Corporation
- ZEROS Dental Implant System
Zeros Co., Ltd.
- Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Showing 12 of 14. Search the rest in openFDA.
Label changesCovers FDA's Wed, Aug 19 (two weeks ago)5 touch MedGrid159
- Dr. Scholls Blister Pain Relief Complete KitTouches MedGrid categories
Scholl's Wellness Company LLC
- Dr. Scholls Blister Pain Relief Complete KitTouches MedGrid categories
Scholl's Wellness Company LLC
- Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickTouches MedGrid categories
Utu Co
- Mineral sunscreenTouches MedGrid categories
Guangzhou Origin Beauty Cosmetics Co., Ltd.
- Aloe UP .5OZ SPF 50 MINERAL SunscreenTouches MedGrid categories
Aloe Care International, LLC
- CVS childrens Cough and Cold
CVS PHARMACY
- Drug label
- nystatin
NuCare Pharmaceuticals,Inc.
- Eagle Brand Muscular Balm
PT. EAGLE INDO PHARMA
- GLATIRAMER ACETATE
Zydus Pharmaceuticals USA Inc.
- CVS Mucus Relief DM Maximum Strength
CVS PHARMACY
- Chlorpromazine
REMEDYREPACK INC.
Showing 12 of 159. Search the rest in openFDA.
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.