The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0887-2018·Announced 2018-06-27

Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures

Dr. Reddy's Laboratories is recalling specific lots of Atorvastatin Calcium tablets because they failed impurity and degradation specifications.

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 specification issues.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling 44,894 bottles of Atorvastatin Calcium tablets, 20 mg, 90-count. The affected products are prescription-only and were manufactured by Dr. Reddy's Laboratories Limited in India. The recall covers specific lots with expiration dates of 07/18 and 04/19.

The recall was initiated because the products failed impurities and degradation specifications. This classification indicates that the defect is unlikely to cause adverse health consequences, but the manufacturer is taking action to ensure product quality.

The affected products were distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should check their medication for the specific lot numbers and expiration dates listed in the recall notice. If the medication matches the recalled lots, it should be returned to the pharmacy or contact the manufacturer for instructions.

The recalled product

Product
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand
ATORVASTATIN CALCIUM
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
44,894

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 (5)

  • Lot #: T600328
  • Exp 07/18
  • T700214
  • T700216
  • Exp 04/19

UPCs (1)

  • 0355111123903

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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Same brand · ATORVASTATIN CALCIUM

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