- 1new drug approvals (since 1 Jan 2023)
- 35drug recalls (since 1 Jan 2023)
- 82device recalls (since 1 Jan 2023)
- 16510(k) clearances (since 1 Jan 2023)
- 78,548side effect reports (reports received since 1 Jan 2023)
Each number has its full source under its own list below.
New drug approvals
1 new medicines approved (since 1 Jan 2023). Medicines with a new active ingredient that the FDA approved, whose label lists a use on this topic.
Journavx (suzetrigine)
Approved for: JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. JOURNAVX is a sodium channel blocker indicated for the treatment…
Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.
Drug recalls
35 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.
Tridacaine III / Lidocaine Patch 5%, 15 envelopes containing 1 patch each per pouch, Rx only, Distributed by: Trifluent Pharma San Antonio, TX 78213, NDC 73352…
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. Incorrect expiration date printed on the label.
Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceut…
Reason: Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zu…
Reason: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL…
Reason: Presence of Particulate Matter: Hair was found in products
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047…
Reason: Presence of Particulate Matter: Hair was found in products
Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL…
Reason: Presence of Particulate Matter: Hair was found in products
Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance,…
Reason: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA…
Reason: Crystallization; identified as Buprenorphine free base
Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.
Device recalls
82 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Reason: Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue that causes the TD to attempt to restart,…
Spinal Epidural Anesthesia Kit
Reason: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection…
Nerve Block Tray
Reason: Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility.
Spinal Epidural Anesthesia Kit
Reason: Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of po…
General Surgery Tray
Reason: 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 injectio…
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason: Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, addit…
Spinal Epidural Anesthesia Kit
Reason: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identi…
Orthopedic Tray
Reason: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason: Sterile anchors my lack sterility assurance.
Spinal Epidural Anesthesia Kit
Reason: Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integri…
Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.
510(k) clearances
16 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.
Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (mist Spray And Medium Spray)
Company: Gebauer Company
Nitrile Powder-free Exam Gloves Tested For Use With Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid And Xylazine In Fentanyl Citrate
Company: Basic Medical Technology, Inc.
Nitrile Powder-free Exam Gloves 2.8, Tested For Use With Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light Blue, Dark Blue)
Company: Basic Medical Technology, Inc.
Nitrile Powder-free Exam Gloves Tested For Use With Chemotherapy Drugs, Opioid Fentanyl Citrate (black,white)
Company: Basic Medical Technology, Inc.
Nitrile Powder-free Exam Gloves Tested For Use With Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light Blue, Dark Blue)
Company: Basic Medical Technology, Inc.
Enhanced Handheld Pain Relief Laser Instrument (gd-p-e)
Company: Wuhan Guangdun Technology Co.,Ltd..
Pain Therapy Device(model: P.t.s-x)
Company: Guangzhou Xinbo Electronic Co., Ltd.
Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.
Side effects people report
78,548 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.
Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.
Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.
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FDA approvals and recalls on related topics
Acuitas market sizes and forecasts are only in our full reports. How we use public data.