The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1145-2015·Announced 2015-06-24

Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

Dr. Reddy's is voluntarily recalling specific lots of Amlodipine and Atorvastatin tablets because they contain less active ingredient than labeled.

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 recall is classified as FDA Class III, which the rubric associates with scores of 1 or 2. A score of 2 is assigned because subpotent drugs represent a functional failure of the medication, which is more significant than a cosmetic defect but less severe than a risk of harm.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is voluntarily recalling Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottles. The recall is limited to Lot # C309280, which was distributed nationwide. The product is identified by NDC 43598-315-90 and was manufactured by Dr. Reddy's Laboratories Limited in Bachupally, India.

The reason for the recall is that the tablets are subpotent, meaning they contain less of the active drug ingredients than stated on the label. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Patients who have this specific lot of medication should contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall was initiated on May 6, 2015, and was terminated on March 31, 2016.

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 Drug
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 (1)

  • Lot # C309280

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 4 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 4 products in this recall →

Related recalls

Same brand · AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

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

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Same hazard · subpotent drug

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