Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Amitriptyline HCl Tablets Recalled by Sandoz Incorporated Due to Cross Contamination With Other Product: Imipramine

Date: June 16, 2017
Company: Sandoz Incorporated
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sandoz Incorporated directly.

Affected Products

Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540

Quantity: 38,234 bottles

Why Was This Recalled?

Cross Contamination With Other Product: Imipramine

Where Was This Sold?

Product was distributed throughout the United States

About Sandoz Incorporated

Sandoz Incorporated has 16 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report