The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1143-2015·Announced 2015-06-24

Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

Dr. Reddy's is 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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor issues.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is voluntarily recalling Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg. The recall affects 30-count and 90-count bottles distributed nationwide. The specific lots involved are C401536 and C401538, both with an expiration date of 07/2015.

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. This is a Class III recall, which the FDA defines as a situation where use of or exposure to a violative product is not likely to cause adverse health consequences.

Patients who have these specific medications should check their bottles for the lot numbers and expiration dates listed above. If the medication matches the recalled lots, patients should contact their healthcare provider or pharmacist for guidance on obtaining a replacement prescription. 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 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)

  • Lot #: a) C401536
  • Exp 07/2015
  • b) C401538

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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