Vaseretic — Class III drug recall D-0018-2015
Terminated recall by Valeant Pharmaceuticals North America LLC, reported 2014-10-22, distributed nationwide. Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package o
| Recall number | D-0018-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, United States |
| Recall initiated | 2014-05-21 |
| Classified | 2014-10-10 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2015-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 205,853 bottles |
| Reason classes | labeling |
| NDC | 00187-0146, 00187-0146-01 |
| Lot numbers | 12J022P, 13G047P |
| Expiration dates | 2014-09-30, 2015-07-31 |
Product
Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada
Reason for recall
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
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-0018-2015. 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.