VARENICLINE — Class II drug recall D-803-2014
Terminated recall by Aidapak Services, LLC, reported 2014-01-29, distributed in AZ, CA, OR, WA. Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the followin
| Recall number | D-803-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aidapak Services, LLC, Vancouver, WA, United States |
| Recall initiated | 2013-07-02 |
| Classified | 2014-01-20 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-02-07 |
| Distributed | AZ, CA, OR, WA |
| Quantity | 168 tablets |
| Reason classes | labeling |
| Expiration dates | 2014-05-02, 2014-05-22, 2014-06-12 |
Product
VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069046856.
Reason for recall
Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: W003051, EXP: 6/12/2014; SOTALOL HCL, Tablet, 160 mg, NDC 00093106201, Pedigree: AD22609_10, EXP: 4/30/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: AD62796_4, EXP: 5/22/2014.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-803-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.