Exforge HCT (Novartis) – chemical contamination (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 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 # 0078-9563-89
Brand
Novartis Pharmaceuticals Corp.
Lot Codes / Batch Numbers
Product code: 715512 & 725276, Lot Number: F0034, Exp 08/31/2013, F0035, F0036, F0036A, Exp 10/31/2013, F0038, F0039, F0040, F0041, F0042, Exp 12/31/2013, F0043, Exp 01/31/2014, F0045, Exp 03/31/2014, F0044, F0046, Exp 04/30/2014
Products Sold
Product code: 715512 & 725276; Lot Number: F0034, Exp 08/31/2013; F0035, F0036, F0036A, Exp 10/31/2013; F0038, F0039, F0040, F0041, F0042, Exp 12/31/2013; F0043, Exp 01/31/2014; F0045, Exp 03/31/2014; F0044, F0046, Exp 04/30/2014
Novartis Pharmaceuticals Corp. is recalling Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle due to Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo,. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026