QUEtiapine FUMARATE Tablet (Aidapak Services) – Label Mixup (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
QUEtiapine FUMARATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505313301
Brand
Aidapak Services, LLC
Lot Codes / Batch Numbers
QUEtiapine FUMARATE, Tablet, 100 mg has the following codes Pedigree: W002777, EXP: 6/6/2014, Pedigree: W003825, EXP: 6/27/2014, Pedigree: AD73623_13, EXP: 5/30/2014.
Products Sold
QUEtiapine FUMARATE, Tablet, 100 mg has the following codes Pedigree: W002777, EXP: 6/6/2014; Pedigree: W003825, EXP: 6/27/2014; Pedigree: AD73623_13, EXP: 5/30/2014.
Aidapak Services, LLC is recalling QUEtiapine FUMARATE Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505313301 due to Labeling:Label Mixup; QUEtiapine FUMARATE Tablet, 100 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedig. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling:Label Mixup; QUEtiapine FUMARATE Tablet, 100 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W002776, EXP: 6/6/2014; NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: W003823, EXP: 6/27/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60578_5, EXP: 5/29/2014.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, IN, OR, WA
Page updated: Jan 8, 2026