FDA Drug recall D-329-2014
Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale
- FDA Drug
- Class II
- terminated
- Published 2013-12-18
On 2013-12-18 the FDA classified a Class II recall of Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale by Novartis Pharmaceuticals, citing chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Ta….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-329-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-08 |
| Published | 2013-12-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novartis Pharmaceuticals |
| Distribution | US |
Product
Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9490-07
Reason
Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Identifiers
| code_info | Product code: 710003; Lot Number: F0102, Exp 11/30/2013; F0115, F0116, Exp 01/31/2014; F0105, F0109, F0111, F0112, Exp…Product code: 710003; Lot Number: F0102, Exp 11/30/2013; F0115, F0116, Exp 01/31/2014; F0105, F0109, F0111, F0112, Exp 02/28/2014; F0121, F0122, Exp 05/31/2014; F0125A, F0125W1, Exp 07/31/2014; F0137, F0139, F0140, F0141, F0142, F0144; Exp 11/30/2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-329-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.