Montelukast Sodium Chew Tablet (Aidapak Services) – Incorrect Label (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
MONTELUKAST SODIUM, CHEW Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006071131.
Brand
Aidapak Services, LLC
Lot Codes / Batch Numbers
MONTELUKAST SODIUM, CHEW Tablet, 4 mg has the following codes: Pedigree: AD76639_11, EXP: 5/31/2014.
Products Sold
MONTELUKAST SODIUM, CHEW Tablet, 4 mg has the following codes: Pedigree: AD76639_11, EXP: 5/31/2014.
Aidapak Services, LLC is recalling MONTELUKAST SODIUM, CHEW Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 0000607113 due to Labeling: Label Mixup: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the following drug: DICYCLOMINE HCL, Tablet, 20 mg, NDC. 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: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the following drug: DICYCLOMINE HCL, Tablet, 20 mg, NDC 00591079501, Pedigree: AD76639_4, EXP: 5/31/2014.
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 7, 2026