US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Class II · Moderate risk Terminated

Allopurinol Tablets 100mg

Reason Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.

Preferred Pharmaceuticals, Inc. D-0173-2023
Class II · Moderate risk Terminated

Diltiazem Hydrochloride Extended-Release Capsules

Reason Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

Sun Pharmaceutical Industries INC NDC 47335-679-81 D-0262-2023
Class II · Moderate risk Terminated

Sterile Water for Injection

Reason CGMP Deviations: potential for trace amounts of product carryover.

Nephron Sc Inc NDC 0487-6105-01 D-0178-2023
Class II · Moderate risk Terminated

0.9% Sodium Chloride Injection

Reason CGMP Deviations: potential for trace amounts of product carryover.

Nephron Sc Inc D-0177-2023
Class II · Moderate risk Terminated

Allopurinol Tablets USP

Reason Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.

Accord Healthcare, Inc. NDC 16729-134-01 D-0168-2023
Class II · Moderate risk Terminated

Metoprolol Succinate Extended-Release Tablets

Reason Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.

Amerisource Health Services LLC NDC 68001-501-00 D-0269-2023
Class II · Moderate risk Ongoing

Humatrix Microclysmic Gel

Reason CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Consolidated Chemical, Inc D-0326-2023
Class II · Moderate risk Ongoing

Techni-Care Chloroxylenold 3%

Reason CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Consolidated Chemical, Inc D-0325-2023
Class II · Moderate risk Terminated

Rocuronium Bromide Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-0099-2023
Class II · Moderate risk Terminated

TriMix Injection

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0126-2023
Class II · Moderate risk Terminated

BiMix STD 001

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0125-2023
Class II · Moderate risk Terminated

QuadMix Injectable

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0124-2023
Class II · Moderate risk Terminated

TriMix Plus 002

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0123-2023
Class II · Moderate risk Terminated

BiMix Injection

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0122-2023
Class II · Moderate risk Terminated

TriMix Injection

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0121-2023
Class II · Moderate risk Terminated

QuadMix Injectable

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0120-2023
Class II · Moderate risk Terminated

TriMix Injection

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0118-2023
Class II · Moderate risk Terminated

TriMix Plus 001

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0117-2023
Class II · Moderate risk Terminated

TriMix Injection

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0116-2023