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Week of Sep 8, 2025

23

Sep 9, 2025approval355d agoTEPEZZA (TEPROTUMUMAB-TRBW) — FDA approvalteprotumumab

Sponsor: HORIZON THERAPEUTICS IRELAND. Form: INJECTABLE. Route: INJECTION

full page →teprotumumab →fda approvals ↗

Sep 10, 2025approval354d agoKOSELUGO (SELUMETINIB SULFATE) — FDA approvalselumetinib sulfate

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

full page →selumetinib sulfate →fda approvals ↗

Sep 10, 2025approval354d agoKOSELUGO (SELUMETINIB) — FDA approvalselumetinib sulfate

Sponsor: ASTRAZENECA. Form: CAPSULE. Route: ORAL

full page →selumetinib sulfate →fda approvals ↗

Sep 10, 2025approval354d agoOSENVELT (DENOSUMAB-BMWO) — FDA approvalOSENVELT

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION

full page →OSENVELT →fda approvals ↗

Sep 10, 2025approval354d agoCABOMETYX (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

Sponsor: EXELIXIS INC. Form: TABLET. Route: ORAL

full page →cabozantinib s-malate →fda approvals ↗

Sep 10, 2025recall354d agoBoothwyn Pharmacy LLC recall (Cls II)Novo Nordisk AS

Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy — Reason: Subpotent Drug — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoDermaRite Industries, LLC recall (Cls I)

PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08 — Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoB BRAUN MEDICAL INC recall (Cls I)B. Braun Medical Inc

0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09 — Reason: Presence of Particulate Matter. — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoDermaRite Industries, LLC recall (Cls I)

DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08 — Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoBoothwyn Pharmacy LLC recall (Cls III)

Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 — Reason: Subpotent Drug — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoDermaRite Industries, LLC recall (Cls I)

DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. — Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoDermaRite Industries, LLC recall (Cls I)

KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34 — Reason: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoAmneal Pharmaceuticals, LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoBoothwyn Pharmacy LLC recall (Cls II)Novo Nordisk AS

Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy — Reason: Subpotent Drug — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoB BRAUN MEDICAL INC recall (Cls I)B. Braun Medical Inc

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07 — Reason: Presence of Particulate Matter — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoIMMUNOCORE, LLC recall (Cls II)Immunocore Holdings plc

KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026 — Reason: Subpotent Drug — Status: Ongoing

full page →fda recalls ↗

Sep 10, 2025recall354d agoBoothwyn Pharmacy LLC recall (Cls II)Novo Nordisk AS

Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy — Reason: Subpotent Drug — Status: Ongoing

full page →fda recalls ↗

Sep 11, 2025approval353d agoEPKINLY (EPCORITAMAB-BYSP) — FDA approvalepcoritamab

Sponsor: GENMAB US, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →epcoritamab →fda approvals ↗

Sep 11, 2025approval353d agoILLUCCIX (GALLIUM GA-68 GOZETOTIDE) — FDA approvalILLUCCIX

Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS

full page →ILLUCCIX →fda approvals ↗

Week of Sep 15, 2025

27

Sep 15, 2025approval349d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗

Sep 16, 2025approval

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