Vasotec — Class III drug recall D-0019-2015
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 i
| Recall number | D-0019-2015 |
|---|---|
| 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 | 00187-0140, 00187-0140-30, 00187-0140-90, 00187-0141, 00187-0141-10, 00187-0141-30, 00187-0141-90, 00187-0142, 00187-0142-10, 00187-0142-30, 00187-0142-90, 00187-0143, 00187-0143-10, 00187-0143-30, 00187-0143-90 |
| Expiration dates | 2014-05-31, 2014-09-30, 2014-11-30, 2015-02-28, 2015-06-30, 2015-07-31, 2015-09-30, 2015-11-30, 2015-12-31 |
Product
Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles
Reason for recall
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
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-0019-2015. 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.