FDA daily for Wednesday, August 12, 2026
273 FDA records across 6 sections. 16 touch MedGrid's categories and are listed first.
Drug approvalsCovers FDA's Wed, Aug 5 (a week ago)8
- SIMVASTATIN
SIMVASTATIN — WATSON LABS TEVA
- ORZEYFUL
OVEPOREXTON — TAKEDA PHARMS USA
- RANOLAZINE
RANOLAZINE — UMEDICA
- LAMOTRIGINE
LAMOTRIGINE — AMNEAL PHARMS
- ASPIRIN AND DIPYRIDAMOLE
ASPIRIN, DIPYRIDAMOLE — PH HEALTH
- NAPROXEN
NAPROXEN — TP ANDA HOLDINGS
- ESLICARBAZEPINE ACETATE
ESLICARBAZEPINE ACETATE — AUROBINDO PHARMA
- FENOFIBRATE
FENOFIBRATE — MYLAN PHARMS INC
Drug recallsCovers FDA's Wed, Aug 5 (a week ago)6
- Ascend Laboratories, LLC
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS… — Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
- Ascend Laboratories, LLC
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICAL… — Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
- Glenmark Pharmaceuticals Inc., USA
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52. — CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
- MYLAN PHARMACEUTICALS INC
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386… — Presence of precipitate
- MICRO LABS USA INC
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. N… — Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
- Ascend Laboratories, LLC
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICA… — Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Food and supplement recallsCovers FDA's Wed, Aug 5 (a week ago)3
- Galliker Dairy Co, Inc.
DQ Chocolate Reduced Fat Ice Cream Mix, 5 GAL (18.9L). Keep refrigerated. — Foreign material found in product (identified as metal shavings)
- Nelson & Isa Lacteos LLC
Requeson (soft ricotta) 1 lb. packed into a clear clamshell package with no labeling information. "Requeson" is handwritten in black marker on the top lid of the clamshell package. No lot code or UPC. — Products may be contaminated with Listeria monocytogenes.
- Mellish Island Corp
Mellish Island Super Skin; Dietary Supplement; 60 Capsules, 2 per day; Distributed by Mellish Island Corp. UPC: 8 58792 00332 3 — Firm's finished product label does not declare the source of marine collagen which was determined to be fish.
Device recallsCovers FDA's Wed, Aug 5 (a week ago)12 touch MedGrid42
- Windstone Medical Packaging, Inc.Touches MedGrid categories
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A; 2) Universal Block Tray- RX, Part Number AMS2009; 3) Nerve Block Tray - RX, Part Nu… — Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplie…
- Windstone Medical Packaging, Inc.Touches MedGrid categories
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281B;… — Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplie…
- Windstone Medical Packaging, Inc.Touches MedGrid categories
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A. — 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…
- Windstone Medical Packaging, Inc.Touches MedGrid categories
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19 — Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplie…
- Windstone Medical Packaging, Inc.Touches MedGrid categories
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B — Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplie…
- Windstone Medical Packaging, Inc.Touches MedGrid categories
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414 — Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplie…
- Terex UtilitiesTouches MedGrid categories
Power Over Fiber Base Module — Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted l…
- Windstone Medical Packaging, Inc.Touches MedGrid categories
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro Pack, Pack Number AMS12195D; 3) Neuro Pack, Pack Number AMS12307; 4) Neuro Spine Pack… — 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…
- Windstone Medical Packaging, Inc.Touches MedGrid categories
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, P… — 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…
- Windstone Medical Packaging, Inc.Touches MedGrid categories
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A — Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplie…
- Windstone Medical Packaging, Inc.Touches MedGrid categories
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) Nerv… — Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplie…
- Windstone Medical Packaging, Inc.Touches MedGrid categories
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461 — Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplie…
Showing 12 of 42. Search the rest in openFDA.
Device clearancesCovers FDA's Wed, Jul 29 (two weeks ago)11
- CPS Locator 3D Plus Delivery Catheter
CenterPoint Systems, LLC
- NAMIC Dilator and Sheath
Medline Industries, LP
- Suture Button Repair System
Skeletal Dynamics, Inc.
- SSPC NXT Delivery Catheter
CenterPoint Systems, LLC
- CraniUS Plate
CraniUS, LLC
- SPINEART Navigation Instrument System
Spineart SA
- Cleerly LABS
Cleerly, Inc.
- Stone Clear (BWSC-LP9-02)
Sonomotion, Inc.
- Emanate Tray
Emanate Biomedical
- Profoject Dual-Safety Pen Needles
CMT Health PTE., Ltd.
- Cleerly Plaque
Cleerly, Inc.
Label changesCovers FDA's Wed, Jul 29 (two weeks ago)4 touch MedGrid203
- MOUNJAROTouches MedGrid categories
A-S Medication Solutions
- norgestimate and ethinyl estradiolTouches MedGrid categories
PD-Rx Pharmaceuticals, Inc.
- ENDOMETRINTouches MedGrid categories
Ferring Pharmaceuticals Inc.
- Aspercreme Lidocaine No-Mess plus LavenderTouches MedGrid categories
Chattem, Inc.
- SILDENAFIL CITRATE
PD-Rx Pharmaceuticals, Inc.
- Betamethasone Dipropionate
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Ondansetron
A-S Medication Solutions
- Cephalexin
AvKARE
- Cleocin Phosphate
Pharmacia & Upjohn Company LLC
- Busulfan
Sagent Pharmaceuticals
- Caspofungin Acetate
Sagent Pharmaceuticals
- Azithromycin Dihydrate
PD-Rx Pharmaceuticals, Inc.
Showing 12 of 203. 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.