US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

Rifampin Capsules USP

Reason Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.

Lupin Pharmaceuticals Inc. NDC 68180-659-06 D-0100-2023
Class II · Moderate risk Terminated

Menastil

Reason cGMP Deviations

Atlantic Management Resources Ltd. NDC 66233-711-01 D-0084-2023
Class II · Moderate risk Terminated

ProSirona

Reason cGMP Deviations

Atlantic Management Resources Ltd. NDC 66233-712-01 D-0083-2023
Class II · Moderate risk Terminated

Neuroquell

Reason cGMP Deviations

Atlantic Management Resources Ltd. D-0082-2023
Class II · Moderate risk Terminated

Neuroquell Plus

Reason cGMP Deviations

Atlantic Management Resources Ltd. D-0081-2023
Class II · Moderate risk Terminated

Thiamine Hydrochloride 3000 mg/30 mL

Reason Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.

McGuff Compounding Pharmacy Services, Inc. D-0267-2023
Class II · Moderate risk Terminated

Thiamine Hydrochloride 200 mg/2mL

Reason Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.

McGuff Compounding Pharmacy Services, Inc. D-0266-2023
Class II · Moderate risk Terminated

Quinapril Tablets USP

Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Lupin Pharmaceuticals Inc. NDC 68180-558-09 D-0089-2023
Class II · Moderate risk Terminated

Quinapril Tablets USP

Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Lupin Pharmaceuticals Inc. NDC 68180-554-09 D-0088-2023
Class II · Moderate risk Terminated

Desmopressin Acetate Tablet

Reason Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.

RemedyRepack Inc. D-0077-2023
Class II · Moderate risk Terminated

Oxcarbazepine Tablets 600mg

Reason Presence of foreign substance

Sun Pharmaceutical Industries INC NDC 62756-185-88 D-0085-2023
Class II · Moderate risk Terminated

FentaNYL Citrate 2.5 mg/50 mL

Reason Underfilled units.

OurPharma LLC NDC 73013-001-01 D-0078-2023
Class II · Moderate risk Terminated

Sensorcaine-MPF

Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Fresenius Kabi USA, LLC NDC 63323-468-01 D-0129-2023
Class II · Moderate risk Terminated

Sensorcaine

Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Fresenius Kabi USA, LLC NDC 63323-463-01 D-0128-2023
Class II · Moderate risk Terminated

Sensorcaine

Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Fresenius Kabi USA, LLC NDC 63323-461-01 D-0127-2023
Class II · Moderate risk Terminated

PF-Neostigmine Methylsulfate Injection

Reason CGMP Deviations: Potential for cross contamination due to product carry over.

Nephron Sterile Compounding Center LLC NDC 69374-932-33 D-0065-2023
Class II · Moderate risk Terminated

PF-Labetalol HCl Injection

Reason CGMP Deviations: Potential for cross contamination due to product carry over.

Nephron Sterile Compounding Center LLC NDC 69374-946-34 D-0064-2023
Class II · Moderate risk Terminated

Phenoxybenzamine Hydrochloride Capsules

Reason Failed Impurities/Degradation Specifications

Par Formulations Private Limited NDC 49884-038-01 D-0061-2023