Drugs Recalls
17,415 recalls in this category
FDA Drug
Class II
Ongoing
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
October 10, 2025
CA BOTANA International, Inc.
4890 bottles units
FDA Drug
Class III
Ongoing
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
October 10, 2025
Endo USA, Inc.
2,035 cartons units
FDA Drug
Class II
Ongoing
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
October 10, 2025
The Harvard Drug Group, LLC
FDA Drug
Class II
Ongoing
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: 35192-020-0
October 10, 2025
CA BOTANA International, Inc.
810 tubes units
FDA Drug
Class II
Ongoing
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
October 10, 2025
CA BOTANA International, Inc.
874 tubes units
FDA Drug
Class II
Ongoing
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
October 10, 2025
QuVa Pharma, Inc.
75,885 syringes units
FDA Drug
Class II
Ongoing
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
October 10, 2025
CA BOTANA International, Inc.
3295 bottles units
FDA Drug
Class II
Ongoing
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
October 10, 2025
CA BOTANA International, Inc.
1401 tubes units
FDA Drug
Class II
Ongoing
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
October 10, 2025
CA BOTANA International, Inc.
1617 tubes units
FDA Drug
Class III
Ongoing
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
October 10, 2025
Endo USA, Inc.
935 cartons units
FDA Drug
Class III
Ongoing
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuti
October 10, 2025
Alembic Pharmaceuticals Limited
4,884 30-count bottles units
FDA Drug
Class II
Ongoing
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
October 10, 2025
CA BOTANA International, Inc.
4890 bottles units
FDA Drug
Class III
Ongoing
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91
October 10, 2025
Endo USA, Inc.
6,655 cartons units
FDA Drug
Class III
Ongoing
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
October 9, 2025
STAQ Pharma, Inc.
FDA Drug
Class II
Ongoing
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
October 9, 2025
ibspot
3 boxes units
FDA Drug
Class II
Ongoing
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
October 9, 2025
USV Private Limited
8,952 bottles units
FDA Drug
Class II
Ongoing
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
October 9, 2025
Amerisource Health Services LLC
27,868 blister packs units
FDA Drug
Class III
Ongoing
Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.
October 9, 2025
STAQ Pharma, Inc.
FDA Drug
Class III
Ongoing
FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.
October 9, 2025
STAQ Pharma, Inc.
FDA Drug
Class II
Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barc
October 9, 2025
Breckenridge Pharmaceutical, Inc
172,263 bottles units
FDA Drug
Class II
Ongoing
Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850.
October 8, 2025
ASTRAZENECA PHARMACEUTICALS
916 pre-filled syringes units
FDA Drug
Class II
Ongoing
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
October 7, 2025
Teva Pharmaceuticals USA, Inc.
291,512 bottles units
FDA Drug
Class II
Ongoing
Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals
October 7, 2025
Rising Pharma Holding, Inc.
2,064 100-count bottles units
FDA Drug
Class II
Ongoing
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
October 7, 2025
Teva Pharmaceuticals USA, Inc.
181,659 bottles units
FDA Drug
Class II
Ongoing
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500
October 7, 2025
Teva Pharmaceuticals USA, Inc.
107,673 units
FDA Drug
Class II
Ongoing
Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-
October 6, 2025
VIONA PHARMACEUTICALS INC
13080 bottles units
FDA Drug
Class II
Ongoing
Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Bruns
October 6, 2025
Heritage Pharmaceuticals, Inc.
8,754 bottles. units
FDA Drug
Class II
Ongoing
Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Bruns
October 6, 2025
Heritage Pharmaceuticals, Inc.
3,750 bottles. units
FDA Drug
Class II
Ongoing
Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Bru
October 6, 2025
Heritage Pharmaceuticals, Inc.
6,979 bottles. units
FDA Drug
Class II
Ongoing
Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Bruns
October 6, 2025
Heritage Pharmaceuticals, Inc.
5880 bottles. units
FDA Drug
Class II
Ongoing
Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brun
October 6, 2025
Heritage Pharmaceuticals, Inc.
5,882 bottles. units
FDA Drug
Class II
Ongoing
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Bruns
October 6, 2025
Heritage Pharmaceuticals, Inc.
2,418 bottles. units
FDA Drug
Class II
Ongoing
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
October 3, 2025
Advanced Pharmaceutical Technology, Inc.
22,843 pellets units
FDA Drug
Class II
Ongoing
ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25
October 1, 2025
Church & Dwight Co., Inc.
21,912 bottles units
FDA Drug
Class II
Ongoing
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
October 1, 2025
Aspiro Pharma Limited
FDA Drug
Class II
Ongoing
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
September 29, 2025
Acella Pharmaceuticals, LLC
4,680 500-count bottles units
FDA Drug
Class II
Ongoing
AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case,
September 29, 2025
Acuity Specialty Products, Inc.
FDA Drug
Class II
Ongoing
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 Driv
September 29, 2025
Medline Industries, LP
222,800 eaches units
FDA Drug
Class II
Ongoing
Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Config
September 29, 2025
Acuity Specialty Products, Inc.
FDA Drug
Class II
Ongoing
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton,
September 26, 2025
Dr. Reddy's Laboratories, Inc.
571 vials units
FDA Drug
Class II
Ongoing
Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344
September 25, 2025
SV Labs Prescott Corporation
11,386 tubes units
FDA Drug
Class II
Ongoing
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-
September 24, 2025
Zydus Pharmaceuticals USA Inc
912 30-count bottles units
FDA Drug
Class II
Ongoing
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-92
September 24, 2025
Zydus Pharmaceuticals USA Inc
600 30-count bottles units
FDA Drug
Class II
Ongoing
Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015
September 23, 2025
ACME UNITED CORPORATION
2338 boxes units
FDA Drug
Class II
Ongoing
Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.
September 23, 2025
Park Avenue Compounding
189 bags units
FDA Drug
Class II
Terminated
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.
September 22, 2025
RC Outsourcing, LLC
2,669 syringes units
FDA Drug
Class II
Ongoing
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories,
September 19, 2025
Ascend Laboratories LLC
FDA Drug
Class II
Ongoing
Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, D
September 19, 2025
Ascend Laboratories LLC
FDA Drug
Class II
Ongoing
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laborat
September 19, 2025
Ascend Laboratories LLC
141,984 bottles units
FDA Drug
Class II
Ongoing
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. Ind
September 19, 2025
Ascend Laboratories LLC