Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    a) Lot #: C409650, Expiry: 05/2016; Lot #: C409652,Expiry: 05/2016. b) Lot #: C409652, Expiry: 05/2016
  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:
Dr. Reddy's Laboratories, Inc.
Reason for Recall:
Subpotent Drug: Subpotent atorvastatin.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.

Product Codes/Lot Numbers:

a) Lot #: C409650, Expiry: 05/2016; Lot #: C409652,Expiry: 05/2016. b) Lot #: C409652, Expiry: 05/2016

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1378-2015

Related Recalls

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Jun 30, 2025 Prescription Drugs Nationwide View Details →