Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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FDA Drug Recalls

14,806 recalls, newest first

Class II · Moderate risk

Cyclobenzaprine Hydrochloride Tablets

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.

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

GaviLyteTM - C PEG-3350

Failed Stability Specification; Out of specification for Osmolarity

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

Ethosuximide Oral Solution USP 250 mg/5 mL

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

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

Nystatin Oral Suspension

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

Terminated cGMP deviation PAI Holdings, LLC. dba Pharmaceutical Associates Inc NDC 0121-0868-16 D-0721-2021
Class II · Moderate risk

Venlafaxine Tablets

Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg

Terminated Labeling / mix-up Sun Pharmaceutical Industries INC NDC 16714-657-01 D-0703-2021

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