US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Cyclobenzaprine Hydrochloride Tablets

Reason CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.

Teva Pharmaceuticals USA NDC 70199-014-01 D-0775-2021
Class II · Moderate risk Terminated

Cyclobenzaprine Hydrochloride Tablets

Reason CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.

Teva Pharmaceuticals USA NDC 0591-3330-01 D-0774-2021
Class II · Moderate risk Ongoing

Erythromycin Topical Solution USP

Reason Defective container: possibility for lack of seal integrity.

Teligent Pharma, Inc. NDC 52565-027-59 D-0769-2021
Class II · Moderate risk Terminated

Adenosine Injection

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 16714-180-01 D-0748-2021
Class II · Moderate risk Terminated

Leucovorin Calcium for Injection

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 0703-5145-91 D-0747-2021
Class II · Moderate risk Terminated

Leucovorin Calcium for Injection

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 0703-5140-01 D-0746-2021
Class II · Moderate risk Terminated

Alprostadil Injection USP

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 0703-1501-02 D-0742-2021
Class II · Moderate risk Terminated

Metoclopramide Injection USP

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 0703-4502-01 D-0741-2021
Class II · Moderate risk Terminated

Adenosine Injection

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 0703-8776-01 D-0740-2021
Class II · Moderate risk Terminated

Norepinephrine Bitartrate Injection

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 0703-1153-03 D-0739-2021
Class II · Moderate risk Terminated

Epoprostenol Sodium for Injection

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 0703-1995-01 D-0738-2021
Class II · Moderate risk Terminated

Leucovorin Calcium for Injection

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 0703-5145-01 D-0737-2021
Class II · Moderate risk Terminated

GaviLyteTM - C PEG-3350

Reason Failed Stability Specification; Out of specification for Osmolarity

Novel Laboratories, Inc. d.b.a LUPIN NDC 43386-060-19 D-0726-2021
Class II · Moderate risk Terminated

Ethosuximide Oral Solution USP 250 mg/5 mL

Reason Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

PAI Holdings, LLC. dba Pharmaceutical Associates Inc NDC 0121-0670-16 D-0723-2021
Class II · Moderate risk Terminated

Cimetidine Hydrochloride Oral Solution 300 mg/5 mL

Reason Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

PAI Holdings, LLC. dba Pharmaceutical Associates Inc NDC 0121-0649-08 D-0722-2021