Novartis Recalls Exforge HCT Samples Due to Chemical Contamination
Novartis recalls physician sample bottles of Exforge HCT due to contamination with Darocur 1173. Check lot numbers F0012, F0013, and F0014.
Stop using this now
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.
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What happened, in plain English
Novartis Pharmaceuticals Corp. is recalling physician sample bottles of Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) because they may be contaminated with Darocur 1173, a photocuring agent found in the inks on shrink-wrap sleeves. The recall affects specific lots distributed nationwide and in Puerto Rico before August 2013. The record does not specify a remedy or state that the product is safe. Read more at govinfonow.com/recall/46698-novartis-pharmaceuticals-corp-recalls-exforge-hct-amlodipine-valsartan-hydrochlorothiazide-5.
Source Summary by GovInfoNow · govinfonow.com/recall/46698-novartis-pharmaceuticals-corp-recalls-exforge-hct-amlodipine-valsartan-hydrochlorothiazide-5 · Updated October 13, 2026 · FDA enforcement record: FDA #D-332-2014
Cite this page
“Novartis Recalls Exforge HCT Samples Due to Chemical Contamination.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46698-novartis-pharmaceuticals-corp-recalls-exforge-hct-amlodipine-valsartan-hydrochlorothiazide-5. Based on FDA recall #D-332-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-332-2014%22&limit=1).
Why it’s dangerous
The shrink-wrap sleeves on the sample bottles contain ink with Darocur 1173, which can contaminate the tablets inside. The record does not describe the specific health effects of this contamination.
Who’s affected
Patients who received physician sample bottles of Exforge HCT from healthcare providers between the manufacturing dates and August 8, 2013. Individuals in the United States and Puerto Rico are affected.
How to tell if you have this one
Look for physician sample bottles of Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, containing 7 tablets. Check the label for NDC # 0078-9560-89 and Product code 715515. Affected lot numbers are F0012 (Exp 10/31/2013), F0013 (Exp 02/28/2014), and F0014 (Exp 03/31/2014).
- Brand
Novartis- Category
Drug
All 15 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-326-2014 | Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9359-07; Product code: 704412; Lot Number: F1186, Exp 03/31/2014; F1127, F1127A, Exp 07/31/2014 | 139,788 bottles |
| D-327-2014 | Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9360-07; Product code: 704414; Lot Number: F1027; Exp 2/28/2014 | 57,881 bottles |
| D-328-2014 | Exforge (amlodipine and valsartan Tablets) 5/160 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 # 0078-9488-07; Product code: 709999 & 725275; Lot Number: F0048A, Exp 08/31/2013; F0056A, Exp 10/31/2013; F0084, F0085, Exp 01/31/2014; F0059A, F0088, Exp 02/28/2014; F0086, F0087, Exp 03/31/2014; F0061A, F0063W1, Exp 05/31/2014; F0070A, Exp 09/30/2014; F0082A, Exp 02/28/2015 | 1,492,475 bottles |
| D-329-2014 | 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; 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 | 869,951 bottles |
| D-330-2014 | 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; 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 | 281,935 bottles |
| D-331-2014 | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 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 # 0078-9559-89; Product code: 715523 & 725278; Lot Number: F0019, F0019A, Exp 08/31/2013; F0020, Exp 09/30/2013; F0021, F0021A, Exp 10/31/2013; F0022, F0025, Exp 11/30/2013; F0024, F0026, Exp 12/31/2013; F0027, Exp 09/30/2014 | 328,543 bottles |
| D-332-2014 | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 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 # 0078-9560-89; Product code: 715515; Lot Number: F0012, Exp 10/31/2013; F0013, Exp 02/28/2014; F0014, Exp 03/31/2014 | 174,848 bottles |
| D-333-2014 | 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; Product code: 710011; Lot Number: F0060, Exp 01/31/2014; F0028A, Exp 02/28/2014; F0061, Exp 03/31/2014; F0062, Exp 05/31/2014; F0033A, Exp 10/31/2014; F0037A, Exp 01/31/2015 | 61,1240 bottles |
| D-334-2014 | Exforge (amlodipine and valsartan, Tablets) 10/320 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 # 0078-9491-07; Product code: 710007 & 725277; Lot Number: F0131, Exp 11/30/2013; F0138, Exp 01/31/2014; F0137, F0139, F0140, F0141, F0142, F0142A, Exp 02/28/2014; F0145, F0150, F0157, F0158, Exp 04/30/2014; F0159, F0160, Exp 05/31/2014; F0163, F0165, Exp 07/31/2014; F0184, Exp 01/31/2015 | 951,109 bottles |
| D-335-2014 | Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9354-07; Product code: 707136; Lot Number: F0017, Exp 01/31/2015 | 46,812 bottles |
| D-336-2014 | Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9407-01; Product code: 707156; Lot Number: F0012, Exp 02/28/2014 | 18,665 bottles |
| D-337-2014 | Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9485-07; Product code: 708236; Lot Number: F0116, F0116W1, F0016W2, Exp 09/30/2013; F0117, Exp 02/28/2014; F0118, 6) F0119, Exp 08/31/2014 | 12,6245 bottles |
| D-338-2014 | Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9486-07; Product code: 708239; Lot Number: F0140, F0140W1, Exp 09/30/2013; F0142, Exp 07/31/2014; F0143, Exp 08/31/2014; F0144, Exp 10/31/2014; F0145; Exp 01/31/2015. | 128964 bottles |
| D-339-2014 | Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 , NDC # 0078-9521-89; Product code: 712396; Lot Number: F0026, F0027; Exp 07/31/2014 | 16,693 bottles |
| D-340-2014 | Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9524-89; Product code: 712427; Lot Number: F0036, F0036W1, Exp 08/31/2013; F0038, Exp 06/30/2014; F0039, Exp 08/31/2014. | 70,006 bottles |
What to do — step by step
Stop using the medication
Do not take the recalled physician sample bottles due to potential chemical contamination.
Contact your healthcare provider
Speak with your doctor or pharmacist about replacing the medication and reporting the issue, as no specific remedy is listed in the record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the expiration date for the recalled samples?
The expiration dates vary by lot: October 31, 2013 for lot F0012, February 28, 2014 for lot F0013, and March 31, 2014 for lot F0014.
Where were these products sold?
These are physician samples distributed nationwide and in Puerto Rico, not for sale to the general public.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-332-2014 (August 8, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-332-2014 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.