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Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03. — Reason: Failed Tablet/Capsule Specifications — Status: Ongoing

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Oct 29, 2025recall291d agoLannett Company Inc. recall (Cls II)Lannett Co Inc

Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46 — Reason: Failed Dissolution Specifications — Status: Ongoing

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Oct 29, 2025recall291d agoThe Harvard Drug Group LLC recall (Cls II)Almatica Pharma LLC

Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag). — Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . — Status: Ongoing

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Oct 29, 2025recall291d agoJB Chemicals and Pharmaceuticals Ltd recall (Cls III)Island Pharmaceuticals Ltd

Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10. — Reason: Tablet/Capsules Imprinted with Wrong ID — Status: Ongoing

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Oct 29, 2025recall291d agoibspot recall (Cls II)

Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye yuan qu, X003SR097N — Reason: Marketed Without an Approved NDA/ANDA — Status: Ongoing

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Oct 29, 2025recall291d agoUSV Private Limited recall (Cls II)SOLA Pharmaceuticals Inc

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05 — Reason: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. — Status: Ongoing

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Oct 29, 2025recall291d agoMedline Industries, LP recall (Cls II)

Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30. — Reason: Subpotent Drug — Status: Ongoing

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Oct 29, 2025recall291d agoThe Harvard Drug Group LLC recall (Cls II)Almatica Pharma LLC

Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 — Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . — Status: Ongoing

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Oct 29, 2025recall291d agoJB Chemicals and Pharmaceuticals Ltd recall (Cls III)Island Pharmaceuticals Ltd

Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50 — Reason: Tablet/Capsules Imprinted with Wrong ID — Status: Ongoing

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Oct 29, 2025recall291d agoChurch & Dwight Co., Inc. recall (Cls II)CHURCH & DWIGHT CO INC /DE/

ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25 — Reason: Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient. — Status: Ongoing

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Oct 29, 2025recall291d agoAspiro Pharma Limited recall (Cls II)Aspiro Pharma Ltd

Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label). — Reason: Presence of Particulate Matter: Particulate matter identified as glass — Status: Ongoing

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Oct 29, 2025recall291d agoBristol-Myers Squibb Company recall (Cls II)BRISTOL MYERS SQUIBB CO

Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11 — Reason: Lack of Assurance of Sterility. — Status: Ongoing

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Oct 30, 2025approval290d agoTYRUKO (NATALIZUMAB-SZTN) — FDA approvalnatalizumab biosimilar

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

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Oct 30, 2025approval290d agoVIMIZIM (ELOSULFASE ALFA) — FDA approvalBIOMARIN PHARMACEUTICAL INC

Sponsor: BIOMARIN PHARM. Form: INJECTABLE. Route: INJECTION

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Oct 30, 2025approval290d agoHALDOL (HALOPERIDOL DECANOATE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: INJECTABLE. Route: INJECTION

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Oct 30, 2025approval290d agoAXITINIB — FDA approvalaxitinib SR

Sponsor: APOTEX. Form: TABLET. Route: ORAL

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Oct 30, 2025approval290d agoEVEROLIMUS — FDA approvalPostsurgical Therapeutics Inc

Sponsor: NOVUGEN. Form: TABLET. Route: ORAL

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Oct 31, 2025approval289d agoPENICILLIN V POTASSIUM — FDA approvalNorthstar Rx LLC

Sponsor: CHARTWELL RX. Form: FOR SOLUTION. Route: ORAL

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Oct 31, 2025approval289d agoVOQUEZNA TRIPLE PAK (AMOXICILLIN) — FDA approvalamoxicillin + clarithromycin + vonoprazan

Sponsor: PHATHOM. Form: CAPSULE, TABLET, TABLET. Route: ORAL

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Oct 31, 2025approval289d agoVOQUEZNA DUAL PAK (AMOXICILLIN) — FDA approvalamoxicillin + vonoprazan fumarate

Sponsor: PHATHOM. Form: CAPSULE, TABLET. Route: ORAL

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Oct 31, 2025approval289d agoPENICILLIN V POTASSIUM — FDA approvalNorthstar Rx LLC

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

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Oct 31, 2025approval289d agoPENICILLIN V POTASSIUM — FDA approvalNorthstar Rx LLC

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

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Week of Nov 3, 2025

Nov 3, 2025approval286d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

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Nov 3, 2025approval

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