Independent register of U.S. FDA drug recalls · updated Oct 13, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,543 recalls, newest first.

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
Class II · Moderate risk

GoodSense Aller.Ease

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Terminated Impurity / degradation Perrigo Company PLC NDC 0113-0571-30 D-0357-2022
Class II · Moderate risk

CVS Allergy Relief

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Terminated Impurity / degradation Perrigo Company PLC NDC 69842-698-39 D-0356-2022
Class II · Moderate risk

Kirkland Aller-Fex

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Terminated Impurity / degradation Perrigo Company PLC NDC 63981-571-48 D-0355-2022
Class II · Moderate risk

amazon basic+care

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Terminated Impurity / degradation Perrigo Company PLC NDC 72288-425-78 D-0354-2022
Class II · Moderate risk

up&up allergy relief

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Terminated Impurity / degradation Perrigo Company PLC NDC 11673-571-22 D-0351-2022
Class II · Moderate risk

TopCare Allergy Relief

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Terminated Impurity / degradation Perrigo Company PLC NDC 36800-319-13 D-0350-2022
Class II · Moderate risk

TopCare Allergy Relief

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

Terminated Impurity / degradation Perrigo Company PLC NDC 36800-954-53 D-0349-2022

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