FDA Drug Recalls

948 recalls · Class II, newest first

Class II · Moderate risk Ongoing Apr 11, 2023

Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ…

Reason Lack of Assurance of Sterility: Malformed crimped collar seal

Sanofi-Aventis U.S. LLC NDC 0024-5926-05 D-0575-2023

Class II · Moderate risk Completed Apr 7, 2023

Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm…

Reason CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.

Methapharm Inc NDC 67850-150-10 D-0540-2023

Class II · Moderate risk Terminated Apr 6, 2023

Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0726-30 D-0561-2023

Class II · Moderate risk Terminated Apr 6, 2023

Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-008-30 D-0560-2023

Class II · Moderate risk Terminated Apr 6, 2023

Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0587-90 D-0559-2023

Class II · Moderate risk Terminated Apr 6, 2023

Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0727-30 D-0558-2023

Class II · Moderate risk Terminated Apr 6, 2023

Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0762-30 D-0557-2023

Class II · Moderate risk Ongoing Apr 6, 2023

Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS…

Reason CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.

Pharma Nobis LLC D-0537-2023

Class II · Moderate risk Ongoing Mar 31, 2023

Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule…

Reason CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. D-0566-2023

Class II · Moderate risk Ongoing Mar 31, 2023

Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles

Reason CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. D-0565-2023

Class II · Moderate risk Ongoing Mar 31, 2023

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets

Reason CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. D-0564-2023

Class II · Moderate risk Ongoing Mar 31, 2023

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c)…

Reason CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. D-0563-2023

Class II · Moderate risk Terminated Mar 27, 2023

Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle…

Reason CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.

Jarman's Midwest Cleaning Systems, Inc. D-0872-2023

Class II · Moderate risk Terminated Mar 27, 2023

Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx…

Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Preferred Pharmaceuticals, Inc. NDC 68788-7596-3 D-0506-2023

Class II · Moderate risk Terminated Mar 27, 2023

Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c)…

Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Preferred Pharmaceuticals, Inc. NDC 68788-7595-3 D-0505-2023

Class II · Moderate risk Terminated Mar 27, 2023

Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge…

Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Preferred Pharmaceuticals, Inc. NDC 68788-7594-3 D-0504-2023