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Independent register of U.S. FDA drug recalls · updated Oct 10, 2026

FDA Drug Recalls

142 recalls · Class III, newest first

Jul 28, 2015 Class III · Low risk

QC Quality Choice Loratadine Orally Disintegrating Tablets

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 63868-157-10 D-0019-2016

Jul 24, 2015 Class III · Low risk

Nisoldipine Extended Release Tablets

Failed Dissolution Specifications

Terminated Dissolution failure Shionogi Inc. NDC 59630-501-10 D-1284-2015

Jul 21, 2015 Class III · Low risk

Verapamil Hydrochloride Extended-Release tablets

Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.

Terminated Dissolution failure Apotex Inc. NDC 60505-2742-5 D1834-2015

Jul 21, 2015 Class III · Low risk

Phentermine Hydrochloride Capsules

Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station

Terminated Impurity / degradation PD-Rx Pharmaceuticals, Inc. NDC 55289-791-07 D-0574-2016

Jul 20, 2015 Class III · Low risk

Allopurinol Tablets

Failed Tablet/Capsule Specifications; report of oversized and discolored tablets

Terminated Failed specification Qualitest Pharmaceuticals NDC 0603-2116-28 D-1405-2015

Jul 17, 2015 Class III · Low risk

buPROPion Hydrochloride Extended-¿release Tablets USP

Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.

Terminated Dissolution failure Sun Pharma Global Fze NDC 47335-738-86 D-1345-2015

Jul 16, 2015 Class III · Low risk

Imipramine HCl Tablets

Chemical Contamination; benzophenone leached from the product label varnish

Terminated Chemical / undeclared Mutual Pharmaceutical Company, Inc. NDC 54738-914-01 D-1425-2015

Jul 16, 2015 Class III · Low risk

Imipramine HCl Tablets

Chemical Contamination; benzophenone leached from the product label varnish

Terminated Chemical / undeclared Mutual Pharmaceutical Company, Inc. NDC 54738-913-01 D-1424-2015

Jul 16, 2015 Class III · Low risk

Imipramine HCl Tablets

Chemical Contamination; benzophenone leached from the product label varnish

Terminated Chemical / undeclared Mutual Pharmaceutical Company, Inc. NDC 54738-912-01 D-1423-2015

Jul 16, 2015 Class III · Low risk

Felodipine Extended-Release Tablets

Chemical Contamination; benzophenone leached from the product label varnish

Terminated Chemical / undeclared Mutual Pharmaceutical Company, Inc. NDC 53489-370-01 D-1422-2015

Jul 16, 2015 Class III · Low risk

Felodipine Extended-Release Tablets

Chemical Contamination; benzophenone leached from the product label varnish

Terminated Chemical / undeclared Mutual Pharmaceutical Company, Inc. NDC 53489-369-01 D-1421-2015

Jul 16, 2015 Class III · Low risk

Felodipine Extended-Release Tablets

Chemical Contamination; benzophenone leached from the product label varnish

Terminated Chemical / undeclared Mutual Pharmaceutical Company, Inc. NDC 53489-368-01 D-1420-2015

Jul 14, 2015 Class III · Low risk

Phentermine Hydrochloride Capsules

Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station

Terminated Impurity / degradation KVK-Tech, Inc. NDC 10702-0026-01 D-1371-2015

Jul 13, 2015 Class III · Low risk

Mometasone Furoate Ointment USP

Subpotent drug

Terminated Wrong potency / content Perrigo Israel Pharmaceuticals NDC 45802-0119-37 D-1286-2015

Jul 13, 2015 Class III · Low risk

Intermezzo

Failed dissolution specifications

Terminated Dissolution failure Purdue Pharma L.P. NDC 59011-265-30 D-1278-2015

Jul 6, 2015 Class III · Low risk

Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme…

Subpotent Drug: menthol and methyl salicylate below specification

Terminated Wrong potency / content BioComp Pharma, Inc. NDC 0178-0320-12 D-1233-2015

Jul 2, 2015 Class III · Low risk

Cvs Sugar Free Black Cherry Cough Drops

Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.

Terminated Particulate / foreign matter Bestco, Inc. D-1419-2015

Jun 30, 2015 Class III · Low risk

Panadol (acetaminophen)

Failed Dissolution Specifications

Terminated Dissolution failure GlaxoSmithkline Consmer Healthcare NDC 0135-0135-02 D-1287-2015

Jun 29, 2015 Class III · Low risk

HydrOXYzine Hydrochloride Tablets

Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

Terminated Failed specification Qualitest Pharmaceuticals NDC 0603-3968-21 D-1239-2015

Jun 26, 2015 Class III · Low risk

Metoclopramide Oral Solution

Defective Container: Lids on unit dose cups are not fully qualified.

Terminated Packaging defect VistaPharm, Inc. D-1831-2015

Jun 26, 2015 Class III · Low risk

Desmopressin Acetate Tablets

Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

Terminated Labeling / mix-up American Health Packaging D-1235-2015

Jun 23, 2015 Class III · Low risk

Desmopressin Acetate Tablets

Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

Terminated Labeling / mix-up Actavis Laboratories, FL, Inc. D-1285-2015

Jun 23, 2015 Class III · Low risk

Cortisol-Mc

Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.

Terminated Wrong potency / content Abrams Royal Pharmacy II, LLC NDC 88888-0043-31 D-1231-2015

Jun 18, 2015 Class III · Low risk

Disulfiram tablets

Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.

Terminated Dissolution failure Qualitest Pharmaceuticals NDC 0603-3432-21 D1151-2015

Jun 5, 2015 Class III · Low risk

Carb-O-Philic 40 Cream

CGMP Deviation: Poor container closure of the bulk storage container

Terminated Packaging defect Geritrex Corp NDC 54162-640-03 D-1238-2015

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061