Calendar

Week of Mar 9, 2026

Mar 11, 2026recall172d agoACME UNITED CORPORATION recall (Cls II)ACME UNITED CORP

Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00. — Reason: CGMP Deviations — Status: Ongoing

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Mar 11, 2026recall172d agoACME UNITED CORPORATION recall (Cls II)ACME UNITED CORP

WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01. — Reason: CGMP Deviations — Status: Ongoing

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Mar 11, 2026recall172d agoACME UNITED CORPORATION recall (Cls II)ACME UNITED CORP

1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1000 ea Bulk, Made in USA for : Food Service Resources, Flowery Branch, GA 30542. NDC 0924-7130-00. 3) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Wellstar Cobb Hand Wipes, 1000 ea Bulk, Made in the USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 4) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" FSR Sanitizing Hand Wipes, 1000 ea Bulk, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. Inner Packaging - Instant Hand Sanitizing Wipes 5) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x7" Children's 1000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542 NDC 0924-713-00. Inner packaging -Children's Healthcare of Atlanta — Reason: CGMP Deviations — Status: Ongoing

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Mar 11, 2026recall172d agoTeva Pharmaceuticals USA, Inc recall (Cls II)Terns Pharmaceuticals, Inc.

Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054. — Reason: Failed Dissolution Specifications — Status: Ongoing

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Mar 11, 2026recall172d agoACME UNITED CORPORATION recall (Cls II)ACME UNITED CORP

Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00 — Reason: CGMP Deviations — Status: Ongoing

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Mar 11, 2026recall172d agoANTHONY TRINH, 123Herbals LLC recall (Cls I)Viatris Inc

SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China — Reason: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. — Status: Ongoing

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Mar 12, 2026approval171d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

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Mar 12, 2026approval171d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

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Mar 12, 2026approval171d agoPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN HYDROBROMIDE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Sponsor: HETERO LABS LTD III. Form: SYRUP. Route: ORAL

full page →PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE →fda approvals ↗

Mar 12, 2026approval171d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

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Mar 12, 2026approval171d agoSOLIQUA 100/33 (INSULIN GLARGINE) — FDA approvalToujeo LA

Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS

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Mar 12, 2026approval171d agoPOTASSIUM PHOSPHATES (POTASSIUM PHOSPHATE, DIBASIC) — FDA approvalHospira Inc

Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS

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Mar 12, 2026approval171d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

Sponsor: BIOCON LTD. Form: CAPSULE. Route: ORAL

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Mar 12, 2026approval171d agoFINGOLIMOD HYDROCHLORIDE — FDA approvalFINGOLIMOD HYDROCHLORIDE

Sponsor: BIOCON LTD. Form: CAPSULE. Route: ORAL

full page →FINGOLIMOD HYDROCHLORIDE →fda approvals ↗

Mar 12, 2026approval171d agoADLYXIN (LIXISENATIDE) — FDA approvalADLYXIN

Sponsor: SANOFI-AVENTIS US. Form: SOLUTION. Route: SUBCUTANEOUS

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Mar 12, 2026approval171d agoSUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: SUBCUTANEOUS

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Mar 12, 2026approval171d agoSUNLENCA (LENACAPAVIR SODIUM) — FDA approvallenacapavir sodium LA

Sponsor: GILEAD SCIENCES INC. Form: TABLET. Route: ORAL

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Mar 12, 2026approval171d agoPOMALIDOMIDE — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: CAPSULE. Route: ORAL

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Mar 13, 2026approval170d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

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Mar 13, 2026approval170d agoDAPTOMYCIN — FDA approvalDaptomycin Novo

Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS

full page →Daptomycin Novo →fda approvals ↗

Mar 13, 2026approval170d agoMEFENAMIC ACID — FDA approvalMEFENAMIC ACID

Sponsor: MICRO LABS. Form: CAPSULE. Route: ORAL

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Mar 13, 2026approval170d agoGEMCITABINE HYDROCHLORIDE — FDA approvalGEMCITABINE HYDROCHLORIDE

Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION

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Mar 13, 2026approval170d agoALLOPURINOL SODIUM — FDA approvalALLOPURINOL SODIUM

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

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Mar 13, 2026approval170d agoALLOPURINOL SODIUM — FDA approvalALLOPURINOL SODIUM

Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION

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Mar 13, 2026approval170d agoMETHOTREXATE — FDA approvalMaxtrex

Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS

full page →Maxtrex →fda approvals ↗

Mar 13, 2026approval170d agoPHYTONADIONE — FDA approvalSigyn Therapeutics, Inc.

Sponsor: ORBICULAR. Form: INJECTABLE. Route: INJECTION

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Mar 13, 2026approval170d agoCITALOPRAM HYDROBROMIDE — FDA approvalCITALOPRAM HYDROBROMIDE

Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL

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Week of Mar 16, 2026

Mar 16, 2026approval167d agoNURTEC ODT (RIMEGEPANT SULFATE) — FDA approvalrimegepant sulfate ODT

Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →rimegepant sulfate ODT →fda approvals ↗

Mar 16, 2026approval

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