Ranolazine ER (Aidapak) – 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
RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301
Brand
Aidapak Services, LLC
Lot Codes / Batch Numbers
RANOLAZINE ER, Tablet, 500 mg has the following codes Pedigree: AD23087_1, EXP: 5/2/2014, Pedigree: AD62995_7, EXP: 5/29/2014, Pedigree: W002857, EXP: 6/7/2014, Pedigree: W003538, EXP: 6/21/2014, Pedigree: W003741, EXP: 6/26/2014, Pedigree: AD32757_47, EXP: 5/13/2014, Pedigree: W003648, EXP: 6/25/2014, Pedigree: AD60272_40, EXP: 5/22/2014.
Products Sold
RANOLAZINE ER, Tablet, 500 mg has the following codes Pedigree: AD23087_1, EXP: 5/2/2014; Pedigree: AD62995_7, EXP: 5/29/2014; Pedigree: W002857, EXP: 6/7/2014; Pedigree: W003538, EXP: 6/21/2014; Pedigree: W003741, EXP: 6/26/2014; Pedigree: AD32757_47, EXP: 5/13/2014; Pedigree: W003648, EXP: 6/25/2014; Pedigree: AD60272_40, EXP: 5/22/2014.
Aidapak Services, LLC is recalling RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301 due to Labeling:Label Mixup; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD25452_16,. 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; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD25452_16, EXP: 5/3/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD70585_16, EXP: 5/29/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W002852, EXP: 6/7/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree:
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