The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1144-2015·Announced 2015-06-24

Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

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

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 FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for minor or theoretical risks.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is voluntarily recalling Amlodipine Besylate and Atorvastatin Calcium tablets, 10mg/10mg. The recall covers 30-count and 90-count bottles (NDC 43598-321-30 and NDC 43598-321-90) manufactured in India. The affected lots are C401537 and C401539, both with an expiration date of 07/2015.

The reason for the recall is that the tablets are subpotent, meaning they do not contain the full labeled amount of the active drug ingredients. The FDA classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recall was initiated nationwide on May 6, 2015, and was terminated on March 31, 2016. Patients and healthcare providers should check their medication for the specific lot numbers and NDC codes listed above. If the medication matches the recalled description, it should be returned to the pharmacy or disposed of according to local regulations.

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 (3)

  • Lot #: a) C401537
  • Exp 07/2015
  • b) C401539

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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