Alcon OFAC Settlement: $7.6M (2016)

Last updated: July 20, 2026

Alcon Laboratories, Inc., Alcon Pharmaceuticals Ltd., and Alcon Management, SA settled potential civil liability for apparent violations of the Iranian Transactions and Sanctions Regulations and the Sudanese Sanctions Regulations with the U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) in the amount of $7,617,150.

Penalty Amount

$7,617,150.00

Enforcement Date

July 5, 2016

Rank in Top Penalties

#44

Case Details

Type:: Entity
Name:: Alcon Laboratories, Inc., Alcon Pharmaceuticals Ltd., and Alcon Management, SA
Country:: 🇺🇸 United States
Industry:: Healthcare
Address:: Fort Worth, Texas; Fribourg, Switzerland; Genève, Switzerland
Penalty amount:: $7,617,150.00
Base civil monetary penalty:: $16,927,000.00
Max civil monetary penalty:: $138,982,584.00
Egregious case:: No
Voluntary self disclosure:: No
Case:: Settlement
Violation period:: August 2008 to December 2011
Program:: Iranian Transactions and Sanctions Regulations, 31 C.F.R. part 560 (ITSR)Sudanese Sanctions Regulations, 31 C.F.R. part 538 (SSR)
Enforcement date:: July 5, 2016

Nature of the Apparent Violations

In the course of BIS's and OFAC's investigations, Alcon produced documents and information from which it appeared that from August 2008 to December 2011, Alcon violated section 560.204 of the ITSR on 452 occasions and section 538.205 of the SSR on 61 occasions when it engaged in the sale and exportation of medical end-use surgical and pharmaceutical products from the United States to distributors located in Iran and Sudan without OFAC authorization.

How OFAC Determined the Penalty

OFAC determined that Alcon did not make a voluntary self-disclosure and that the apparent violations were not egregious. The statutory maximum civil monetary penalty amount for the apparent violations was $138,982,584 and the base penalty amount was $16,927,000. The settlement amount of $7,617,150 reflects OFAC's consideration of the General Factors under OFAC's Economic Sanctions Enforcement Guidelines, 31 C.F.R. part 501, app. A.

Alcon's obligation to pay the $7,617,150 settlement amount is satisfied by: (a) Alcon's payment of $1,317,150 to the U.S. Department of the Treasury, (b) its payment to BIS as set forth in the concurrent settlement agreement with BIS, and (c) its compliance with all other terms set forth in the settlement agreement with BIS.

Aggravating Factors

Alcon demonstrated reckless disregard for U.S. sanctions requirements by having virtually no compliance program, despite significant business involving the exportation of goods from the United States to Iran and Sudan, and by failing to take adequate steps to investigate a third-party freight forwarder's cessation of shipments to Iran on behalf of Alcon
Alcon and its then-senior management knew of the conduct giving rise to the apparent violations
Alcon is a sophisticated multinational corporation with extensive experience in international trade

Mitigating Factors

Harm to U.S. sanctions program objectives was limited because the exports involved medical end-use products that were licensable under the Trade Sanctions Reform and Export Enhancement Act of 2000, and in fact had been previously and subsequently licensed by OFAC for Alcon
Alcon has no prior OFAC sanctions history, including receipt of a Penalty Notice or Finding of Violation in the five years preceding the date of the earliest transaction giving rise to the apparent violations, making it eligible for "first violation" mitigation of up to 25 percent
Alcon took remedial action by ceasing the unlicensed exports to sanctioned countries, initiating an internal investigation of the apparent violations, and instituting a robust compliance program that now includes: (a) updated or newly-created corporate export and trade sanctions compliance documents, (b) enhanced trade compliance training, and (c) enhanced compliance procedures for requesting OFAC licenses
Alcon substantially cooperated with OFAC's investigation, including by providing detailed and well-organized information and entering into several statute of limitations tolling agreements with OFAC

Alcon's OFAC settlement is concurrent with a separate settlement agreement with the Department of Commerce's Bureau of Industry and Security (BIS). Alcon's obligation to satisfy the $7,617,150 OFAC settlement amount is partially fulfilled through its payment to BIS under that concurrent agreement and its compliance with all other terms set forth in the BIS settlement.

Official Source Documents

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Archived on June 13, 2026

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