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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Sandoz Incorporated
Reason for Recall:
Cross Contamination With Other Product: Imipramine
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot #: a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0943-2017

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