Exforge — Class II drug recall D-333-2014
Terminated recall by Novartis Pharmaceuticals Corp., reported 2013-12-18, distributed nationwide. Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan,
| Recall number | D-333-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Pharmaceuticals Corp., Suffern, NY, United States |
| Recall initiated | 2013-08-08 |
| Classified | 2013-12-06 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2015-12-21 |
| Distributed | Nationwide (US) |
| Quantity | 61,124 |
| Reason classes | chemical contamination |
| NDC | 00078-9489-07 |
| Lot numbers | F0028A, F0033A, F0037A, F0060, F0061, F0062 |
| Expiration dates | 2014-01-31, 2014-02-28, 2014-03-31, 2014-05-31, 2014-10-31, 2015-01-31 |
Product
Exforge (amlodipine and valsartan Tablets) 10/160 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 # 0078-9489-07
Reason for recall
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.
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-333-2014. 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.