Guaifenesin ER Tablet (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
guaiFENesin ER, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000815
Brand
Aidapak Services, LLC
Lot Codes / Batch Numbers
guaiFENesin ER, Tablet, 600 mg has the following codes Pedigree: AD21965_22, EXP: 5/1/2014, Pedigree: AD56917_13, EXP: 5/21/2014, Pedigree: AD73627_23, EXP: 5/30/2014, Pedigree: W003218, EXP: 6/17/2014, Pedigree: W003360, EXP: 6/19/2014, Pedigree: W002660, EXP: 6/5/2014.
Products Sold
guaiFENesin ER, Tablet, 600 mg has the following codes Pedigree: AD21965_22, EXP: 5/1/2014; Pedigree: AD56917_13, EXP: 5/21/2014; Pedigree: AD73627_23, EXP: 5/30/2014; Pedigree: W003218, EXP: 6/17/2014; Pedigree: W003360, EXP: 6/19/2014; Pedigree: W002660, EXP: 6/5/2014.
Aidapak Services, LLC is recalling guaiFENesin ER, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000815 due to Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21. 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; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21965_13, EXP: 5/1/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD56917_7, EXP: 5/21/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD73627_17, EXP: 5/30/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003216
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 10, 2026