The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0886-2018·Announced 2018-06-27

Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities

Dr. Reddy's Laboratories is recalling Atorvastatin Calcium tablets because they failed impurities 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 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 indicates the product is not likely to cause adverse health consequences, aligning with the Moderate severity criteria for low-risk issues.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Atorvastatin Calcium tablets, 10 mg, 90-count bottles. The recall was initiated because the product failed impurities and degradation specifications.

The affected product is manufactured by Dr. Reddy's Laboratories Limited in Srikakulam, India, and distributed nationwide in the USA and Puerto Rico. The recall covers 55,126 bottles with specific lot numbers and expiration dates listed in the official notice.

Consumers should stop using the recalled medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.

The recalled product

Product
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand
ATORVASTATIN CALCIUM
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
55,126

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 #: T600327
  • Exp 07/18
  • T700213
  • T700215
  • 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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