The Recall Desk
ModerateFDA (Drugs)·D-1146-2015·Announced 2015-06-24

Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

Dr. Reddy's Laboratories is recalling specific lots of Amlodipine Besylate and Atorvastatin Calcium tablets because they contain less than the labeled amount of active ingredients.

What this means for you

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 is defined as unlikely to cause adverse health consequences. While subpotent drugs are a quality issue, the lack of reported harm and the Class III designation align with a Moderate severity rating for a voluntary precautionary action.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is voluntarily recalling Amlodipine Besylate and Atorvastatin Calcium tablets, 5mg/40mg. The recall affects Lot # C402439, which was distributed nationwide. The product is available in 30-count and 90-count bottles under NDC 43598-316-30 and NDC 43598-316-90.

The reason for the recall is that the tablets are subpotent, meaning they do not contain the full amount of active drug ingredients stated on the label. This is a Class III recall, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.

Consumers who have this specific lot of medication should contact their healthcare provider or pharmacist for guidance on obtaining a replacement prescription. The recall was initiated by the firm and has been terminated.

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 (1)

  • Lot # C402439

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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