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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 401–420 of 17,683 recalls

Class IIOngoing

Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.

Safecor Health, LLC

Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

October 10, 2025 · DrugView details →

Class IIOngoing

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

Lannett Company Inc.

Failed Dissolution Specifications

October 10, 2025 · DrugView details →

Class IIOngoing

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).

The Harvard Drug Group LLC

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

October 10, 2025 · DrugView details →

Class IIOngoing

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

CA BOTANA International, Inc.

CGMP Deviations

October 10, 2025 · DrugView details →

Class IIOngoing

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

CA BOTANA International, Inc.

CGMP Deviations

October 10, 2025 · DrugView details →

Class IIIOngoing

Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91

Endo USA, Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

October 10, 2025 · DrugView details →

Class IIOngoing

HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.

Samsung Bioepis Co., Ltd.

Lack of Assurance of Sterility.

October 10, 2025 · DrugView details →

Class IIOngoing

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

CA BOTANA International, Inc.

CGMP Deviations

October 10, 2025 · DrugView details →

Class IIOngoing

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

CA BOTANA International, Inc.

CGMP Deviations

October 10, 2025 · DrugView details →

Class IIOngoing

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

CA BOTANA International, Inc.

CGMP Deviations

October 10, 2025 · DrugView details →

Class IIOngoing

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

CA BOTANA International, Inc.

CGMP Deviations

October 10, 2025 · DrugView details →

Class IIIOngoing

Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91

Endo USA, Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

October 10, 2025 · DrugView details →

Class IIOngoing

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

The Harvard Drug Group LLC

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

October 10, 2025 · DrugView details →

Class IIOngoing

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

CA BOTANA International, Inc.

CGMP Deviations

October 10, 2025 · DrugView details →

Class IIOngoing

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

CA BOTANA International, Inc.

CGMP Deviations

October 10, 2025 · DrugView details →

Class IIOngoing

R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50

QuVa Pharma, Inc.

Presence of Particulate Matter

October 10, 2025 · DrugView details →

Class IIOngoing

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

CA BOTANA International, Inc.

CGMP Deviations

October 10, 2025 · DrugView details →

Class IIOngoing

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

CA BOTANA International, Inc.

CGMP Deviations

October 10, 2025 · DrugView details →

Class IIOngoing

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

CA BOTANA International, Inc.

CGMP Deviations

October 10, 2025 · DrugView details →

Class IIIOngoing

Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91

Endo USA, Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

October 10, 2025 · DrugView details →

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