US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class I · High risk Terminated

Cetylev

Reason Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.

Arbor Pharmaceuticals Inc. NDC 24338-700-10 D-0105-2017
Class II · Moderate risk Terminated

Venlafaxine HCL ER Capsule USP

Reason Failed Dissolution Specifications: out of specification dissolution results in retained samples

Zydus Pharmaceuticals USA Inc NDC 68382-035-06 D-1461-2016
Class II · Moderate risk Terminated

Venlafaxine HCL ER Capsule USP

Reason Failed Dissolution Specifications: out of specification dissolution results in retained samples

Zydus Pharmaceuticals USA Inc NDC 68382-036-06 D-1460-2016
Class II · Moderate risk Terminated

Bactroban Ointment

Reason Penicillin Cross Contamination

GlaxoSmithKline, LLC NDC 0029-1525-44 D-1445-2016
Class II · Moderate risk Terminated

Bactroban Nasal

Reason Penicillin Cross Contamination

GlaxoSmithKline, LLC NDC 0029-1526-11 D-1444-2016
Class II · Moderate risk Terminated

Bactroban Cream

Reason Penicillin Cross Contamination

GlaxoSmithKline, LLC NDC 0029-1527-25 D-1443-2016
Class II · Moderate risk Terminated

Bactroban Cream

Reason Penicillin Cross Contamination

GlaxoSmithKline, LLC NDC 0029-1527-22 D-1442-2016
Class III · Low risk Terminated

Children's Qnasl 40 mcg

Reason Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.

Teva North America NDC 59310-206-08 D-1453-2016
Class I · High risk Terminated

Diocto Liquid

Reason Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia

The Harvard Drug Group NDC 0536-0590-85 D-0022-2017
Class II · Moderate risk Terminated

Trokendi XR

Reason Superpotent Drug: Failure of assay specifications in the capsule.

Supernus Pharmaceuticals, Inc. NDC 17772-102-15 D-0112-2017
Class II · Moderate risk Terminated

Acetylcyst 10% OPHT SOL

Reason Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.

Medicap Pharmacy NDC 99999-9996-94 D-1447-2016
Class II · Moderate risk Terminated

Metronidazole 500mg Tablet

Reason CGMP Deviations

Safecor Health, LLC D-0905-2017
Class II · Moderate risk Terminated

Doxycycline100mg Tablets

Reason CGMP Deviations

Safecor Health, LLC D-0904-2017
Class II · Moderate risk Terminated

Acyclovir 400mg Tablet

Reason CGMP Deviations

Safecor Health, LLC D-0903-2017
Class II · Moderate risk Terminated

Oxygen Nasal Wash

Reason Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.

Let's Talk Health, Inc. D-1452-2016
Class II · Moderate risk Terminated

Glipizide 2.5 mg Extended-release tablets

Reason Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.

Actavis Inc NDC 00591-0900-30 D-1457-2016