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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 241–260 of 703 recalls

Class IIOngoing

AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each

Encon Safety Products Co

cGMP deviations.

January 6, 2026 · DrugView details →

Class IIOngoing

Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67

Cipla USA, Inc.

Presence of Particulate Matter.

January 2, 2026 · DrugView details →

Class II

Ongoing

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.

Wizcure Pharmaa Private Limited

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

December 31, 2025 · DrugView details →

Class IIOngoing

Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.

Wizcure Pharmaa Private Limited

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

December 31, 2025 · DrugView details →

Class IIOngoing

Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.

Wizcure Pharmaa Private Limited

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

December 31, 2025 · DrugView details →

Class IIOngoing

Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.

Wizcure Pharmaa Private Limited

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

December 31, 2025 · DrugView details →

Class IIOngoing

Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.

Wizcure Pharmaa Private Limited

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

December 31, 2025 · DrugView details →

Class IIOngoing

Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.

Alvogen, Inc

Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.

December 31, 2025 · DrugView details →

Class IIOngoing

Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15

AvKARE

Out of specification for dissolution.

December 31, 2025 · DrugView details →

Class IIOngoing

Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.

Wizcure Pharmaa Private Limited

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

December 31, 2025 · DrugView details →

Class IIOngoing

CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,

Wizcure Pharmaa Private Limited

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

December 31, 2025 · DrugView details →

Class IIOngoing

Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13

Glenmark Pharmaceuticals Inc., USA

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

December 30, 2025 · DrugView details →

Class IIIOngoing

Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

December 30, 2025 · DrugView details →

Class IIOngoing

Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07

Zydus Pharmaceuticals (USA) Inc

Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules

December 30, 2025 · DrugView details →

Class IIOngoing

TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670

Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

Incorrect Product Formulation: product did not contain insulin as listed in the label.

December 27, 2025 · DrugView details →

Class IIOngoing

TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

December 26, 2025 · DrugView details →

Class IIOngoing

LIQUID DAYQUIL 12/8oz

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

December 26, 2025 · DrugView details →

Class IIOngoing

EXCEDRIN MIGRAINE 2'S- 25 CT

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

December 26, 2025 · DrugView details →

Class IIOngoing

Swan, White Clear Alcohol, 50%, 16oz, 12 count

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

December 26, 2025 · DrugView details →

Class IIOngoing

Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

December 26, 2025 · DrugView details →

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