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

FDA Drug Recalls

1,711 recalls, newest first

Aug 6, 2015 Class II · Moderate risk

DuraPrep Surgical Solution Iodine Povacrylex

Chemical contamination: Product may be contaminated with a toxic compound.

Terminated Chemical / undeclared 3M Company - Health Care Business NDC 17518-0011-08 D-1417-2015

Aug 6, 2015 Class I · High risk

KABOOM action strips

Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.

Terminated Chemical / undeclared Blue Square Market, Inc. D-0297-2016

Aug 6, 2015 Class I · High risk

LiDa DAIDAIHUA

Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.

Terminated Chemical / undeclared Blue Square Market, Inc. D-0296-2016

Aug 5, 2015 Class III · Low risk

Topicort (desoximetasone)

Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.

Terminated Impurity / degradation Taro Pharmaceuticals, Inc. D-1370-2015

Aug 3, 2015 Class II · Moderate risk

Rivastigmine Tartrate Capsules

Failed Dissolution Specifications

Terminated Dissolution failure Dr. Reddy's Laboratories, Inc. NDC 55111-352-60 D-1325-2015

Jul 30, 2015 Class II · Moderate risk

Hydrochlorothiazide Tablet USP 25 mg

Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.

Terminated Particulate / foreign matter Unichem Pharmaceuticals Usa Inc NDC 29300-128-10 D-1352-2015

Jul 29, 2015 Class II · Moderate risk

Lisinopril Tablets

Failed Dissolution Specifications

Terminated Dissolution failure Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals NDC 0603-4214-60 D-1406-2015

Jul 29, 2015 Class II · Moderate risk

Lisinopril Tablets USP

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Terminated cGMP deviation Wockhardt Usa Inc. NDC 64679-941-06 D-1347-2015

Jul 29, 2015 Class II · Moderate risk

Lisinopril Tablets USP

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Terminated cGMP deviation Wockhardt Usa Inc. NDC 64679-928-06 D-1346-2015

Jul 28, 2015 Class III · Low risk

Dexmethylphenidate HCl Extended-Release

Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.

Terminated Dissolution failure Novartis Pharmaceuticals Corp. D-1430-2015

Jul 28, 2015 Class III · Low risk

Hydralazine Hydrochloride Injection

Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

Terminated Stability / shelf life Fresenius Kabi USA, LLC NDC 63323-614-01 D-1327-2015

Jul 28, 2015 Class III · Low risk

Meijer Loratadine Orally Disintegrating Tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 41250-527-31 D-0039-2016

Jul 28, 2015 Class III · Low risk

Wal-itin Loratadine Orally Disintegrating Tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 0363-0527-69 D-0038-2016

Jul 28, 2015 Class III · Low risk

Sunmark loratadine Orally Disintegrating Tablets

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

Terminated Wrong potency / content Ohm Laboratories, Inc. NDC 49348-930-01 D-0037-2016

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

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