FDA Drug Recalls

1,525 recalls · Class III, newest first

Jul 28, 2015 Class III · Low risk

Up&Up loratadine orally disintegrating tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 11673-527-31 D-0036-2016

Jul 28, 2015 Class III · Low risk

TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 36800-528-69 D-0035-2016

Jul 28, 2015 Class III · Low risk

Safeway Care Loratadine Orally Disintegrating Tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 21130-527-69 D-0034-2016

Jul 28, 2015 Class III · Low risk

Premier Value Loratadine Orally Disintegrating Tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 68016-527-31 D-0033-2016

Jul 28, 2015 Class III · Low risk

Ohm Loratadine Orally Disintegrating Tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 51660-527-31 D-0032-2016

Jul 28, 2015 Class III · Low risk

Major loratadine orally disintegrating tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 0904-5806-15 D-0031-2016

Jul 28, 2015 Class III · Low risk

Leader Loratadine Orally Disintegrating Tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 37205-745-65 D-0030-2016

Jul 28, 2015 Class III · Low risk

HEB Loratadine Orally Disintegrating Tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. D-0029-2016

Jul 28, 2015 Class III · Low risk

Health Mart Pharmacy loratadine orally disintegrating tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 62011-0073-1 D-0028-2016

Jul 28, 2015 Class III · Low risk

Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 24385-0161-52 D-0027-2016

Jul 28, 2015 Class III · Low risk

Fred's Loratadine Orally Disintegrating Tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. D-0026-2016

Jul 28, 2015 Class III · Low risk

Equaline Original Prescription Strength

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 41163-528-69 D-0025-2016

Jul 28, 2015 Class III · Low risk

Discount Drug Mart Food Fair

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

Terminated Wrong potency / content Ohm Laboratories, Inc. D-0024-2016

Jul 28, 2015 Class III · Low risk

CVS Pharmacy

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

Terminated Wrong potency / content Ohm Laboratories, Inc. D-0023-2016

Jul 28, 2015 Class III · Low risk

CareOne Original Prescription Strength

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 41520-525-69 D-0022-2016

Jul 28, 2015 Class III · Low risk

Health Best Choice Care

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

Terminated Wrong potency / content Ohm Laboratories, Inc. D-0021-2016

Jul 28, 2015 Class III · Low risk

Rite Aid Pharmacy loratadine orally disintegrating tablets USP

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

Terminated Wrong potency / content Ohm Laboratories, Inc. D-0020-2016

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

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