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Week of Dec 1, 2025

48

Dec 2, 2025approval256d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 2, 2025approval256d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

Dec 2, 2025approval256d agoOLANZAPINE — FDA approvalTorrent Pharma Inc

Sponsor: TORRENT PHARMS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 2, 2025approval256d agoJAYPIRCA (PIRTOBRUTINIB) — FDA approvalEli Lilly and Co

Sponsor: LOXO ONCOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 2, 2025approval256d agoPROPOFOL — FDA approvalBika Biotechnology Guanzhou Co Ltd

Sponsor: NANJING KING FRIEND. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 2, 2025approval256d agoLEVETIRACETAM — FDA approvalLEVETIRACETAM

Sponsor: KNACK. Form: INJECTABLE. Route: INTRAVENOUS

full page →LEVETIRACETAM →fda approvals ↗

Dec 2, 2025approval256d agoSITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) — FDA approvalmetformin hydrochloride ER

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →metformin hydrochloride ER →fda approvals ↗

Dec 3, 2025approval255d agoERTUGLIFLOZIN — FDA approvalERTUGLIFLOZIN

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

full page →ERTUGLIFLOZIN →fda approvals ↗

Dec 3, 2025approval255d agoMACITENTAN — FDA approvalJOHNSON & JOHNSON

Sponsor: SEASONS BIOTECH. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 3, 2025approval255d agoMACITENTAN — FDA approvalMACITENTAN

Sponsor: MYLAN. Form: TABLET. Route: ORAL

full page →MACITENTAN →fda approvals ↗

Dec 3, 2025approval255d agoOLANZAPINE — FDA approvalolanzapine ODT

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

full page →olanzapine ODT →fda approvals ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoFresenius Kabi USA, LLC recall (Cls I)Fresenius Kabi USA LLC

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale). — Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoMedical Products Laboratories, Inc. recall (Cls II)Revalesio Corp

Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01 — Reason: Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis — Status: Ongoing

full page →fda recalls ↗

Dec 3, 2025recall255d agoCA BOTANA International, Inc. recall (Cls II)CRA INTERNATIONAL, INC.

Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8 — Reason: CGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Dec 4, 2025approval254d agoEPLERENONE — FDA approvalEPLERENONE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →EPLERENONE →fda approvals ↗

Dec 4, 2025approval254d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →topiramate ER →fda approvals ↗

Dec 5, 2025approval253d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)

full page →ONTRUZANT →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: HIBROW HLTHCARE. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: GRANULES. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 5, 2025approval253d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalEon Labs Inc

Sponsor: CHARTWELL MOLECULAR. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: SOLUTION. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 5, 2025approval253d agoOXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: PH HEALTH. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION

full page →RIFADIN →fda approvals ↗

Dec 5, 2025approval253d agoRIFATER (ISONIAZID) — FDA approvalRIFATER

Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

full page →RIFATER →fda approvals ↗

Dec 5, 2025approval253d agoILLUCCIX (GALLIUM GA-68 GOZETOTIDE) — FDA approvalILLUCCIX

Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS

full page →ILLUCCIX →fda approvals ↗

Dec 5, 2025approval253d agoRIFADIN (RIFAMPIN) — FDA approvalRIFADIN

Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL

full page →RIFADIN →fda approvals ↗

Dec 5, 2025approval253d agoETICOVO (ETANERCEPT-YKRO) — FDA approvalETICOVO

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION

full page →ETICOVO →fda approvals ↗

Dec 5, 2025approval253d agoAMANTADINE HYDROCHLORIDE — FDA approvalShinkei Therapeutics LLC

Sponsor: SHREE HARI INTL. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

Dec 5, 2025approval253d agoACETAMINOPHEN — FDA approvalIGC Pharma, Inc.

Sponsor: CAPLIN. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Dec 5, 2025approval253d agoARIKAYCE KIT (AMIKACIN SULFATE) — FDA approvalamikacin sulfate PR

Sponsor: INSMED INC. Form: SUSPENSION, LIPOSOMAL. Route: INHALATION

full page →amikacin sulfate PR →fda approvals ↗

Week of Dec 8, 2025

2

Dec 8, 2025approval250d agoWINREVAIR (SOTATERCEPT-CSRK) — FDA approvalsotatercept

Sponsor: MERCK SHARP DOHME. Form: INJECTABLE. Route: INJECTION

full page →sotatercept →fda approvals ↗

Dec 8, 2025approval

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