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FDA Drug Recalls

316 recalls, newest first

Class II · Moderate risk Ongoing Dec 13, 2023

Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC…

Reason CGMP Deviations: Stability data does not support expiry date.

Private Label Partners, Inc. NDC 42582-900-06 D-0152-2024

Class II · Moderate risk Ongoing Dec 11, 2023

Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla…

Reason CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

Legacy Pharmaceutical Packaging LLC NDC 68645-523-54 D-0205-2024

Class II · Moderate risk Ongoing Dec 11, 2023

NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. -…

Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc NDC 51552-0041-1 D-0157-2024

Class II · Moderate risk Ongoing Dec 11, 2023

NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. -…

Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc NDC 51552-0041-4 D-0156-2024

Class II · Moderate risk Ongoing Dec 11, 2023

NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. -…

Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc NDC 51552-0041-3 D-0155-2024

Class II · Moderate risk Ongoing Dec 11, 2023

NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400…

Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc NDC 51552-0041-5 D-0154-2024

Class I · High risk Ongoing Nov 29, 2023

Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7…

Reason Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

Meta Herbal D-0206-2024

Class I · High risk Ongoing Nov 22, 2023

SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue…

Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

Novartis Pharmaceuticals Corporation NDC 0078-0110-22 D-0144-2024

Class I · High risk Ongoing Nov 13, 2023

Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 76168-800-30 D-0311-2024

Class I · High risk Ongoing Nov 13, 2023

Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 0536-1282-94 D-0310-2024

Class I · High risk Ongoing Nov 13, 2023

Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 11822-4811-3 D-0309-2024

Class I · High risk Ongoing Nov 13, 2023

Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 11822-2254-3 D-0308-2024

Class I · High risk Ongoing Nov 13, 2023

Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 11822-4540-3 D-0307-2024

Class I · High risk Ongoing Nov 13, 2023

Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 11822-4540-5 D-0306-2024

Class I · High risk Ongoing Nov 13, 2023

CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 76168-711-15 D-0305-2024

Class I · High risk Ongoing Nov 13, 2023

LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 11822-4811-5 D-0304-2024

Class I · High risk Ongoing Nov 13, 2023

EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 79903-168-01 D-0303-2024

Class I · High risk Ongoing Nov 13, 2023

Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 76168-502-30 D-0302-2024

Class I · High risk Ongoing Nov 13, 2023

Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 70000-0587-1 D-0301-2024

Class I · High risk Ongoing Nov 13, 2023

Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL)…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 11673-522-15 D-0300-2024

Class I · High risk Ongoing Nov 13, 2023

Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 70000-0089-1 D-0299-2024

Class I · High risk Ongoing Nov 13, 2023

CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack)…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 76168-704-15 D-0298-2024

Class I · High risk Ongoing Nov 13, 2023

Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL)…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 70000-0087-1 D-0297-2024

Class I · High risk Ongoing Nov 13, 2023

CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL)…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 76168-706-15 D-0296-2024

Class I · High risk Ongoing Nov 13, 2023

Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles…

Reason Non-Sterility

Kilitch Healthcare India Limited NDC 70000-0088-1 D-0295-2024