The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1377-2015·Announced 2015-09-02

Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

Dr. Reddy's Laboratories is recalling Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component is subpotent.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as a violation not likely to cause adverse health consequences. This aligns with the rubric for moderate severity involving minor labeling or quality errors without reported harm.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Amlodipine Besylate and Atorvastatin Calcium Tablets, 10 mg/20 mg, due to subpotent atorvastatin. The affected product is packaged in 30-count and 90-count bottles and is available by prescription only. The specific lot number is C404592 with an expiration date of 11/2015.

The recall covers 16,080 bottles of the 30-count package and 480 bottles of the 90-count package. These products were distributed nationwide in the United States. The tablets were manufactured by Dr. Reddy's Laboratories Limited in India.

Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The FDA has classified this recall as Class III, indicating that the violation is not likely to cause adverse health consequences.

The recalled product

Product
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
Brand
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • a) Lot #: C404592
  • Expiry: 11/2015. b) Lot #: C404592
  • Expiry: 11/2015

UPCs (9)

  • 0343598323305
  • 0343598315300
  • 0343598320304
  • 0343598317304
  • 0343598313306
  • 0343598322308
  • 0343598319308
  • 0343598316307
  • 0343598314303

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same brand · AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Same manufacturer · Dr. Reddy's Laboratories, Inc.

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