The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0888-2018·Announced 2018-06-27

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

Dr. Reddy's Laboratories is recalling 130,081 bottles of Atorvastatin Calcium 40 mg tablets nationwide due to 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 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 a low probability of adverse health consequences, aligning with the Moderate severity rating for minor or low-risk issues.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling 130,081 bottles of Atorvastatin Calcium Tablets, 40 mg, in 90-count and 500-count bottles. The affected products are distributed nationwide in the USA and Puerto Rico. The recall is being conducted because the products failed impurities and degradation specifications.

The specific lots involved include T600392, T600384, T600353, T600427, T600435, T600492, T700006, T700014, T700033, T700035, T700036, and T600407, with expiration dates ranging from August 2018 to December 2018. The products are manufactured by Dr. Reddy's Laboratories Limited in India.

Consumers should check their medication for the NDC numbers 55111-123-90 or 55111-123-05 and the lot numbers listed above. If the medication matches the recalled description, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand
ATORVASTATIN CALCIUM
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
130,081

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 (16)

  • Lot #: a) T600392
  • T600384
  • T600353
  • Exp 08/18
  • T600427
  • Exp 09/18
  • T600435
  • Exp 10/18
  • T600492
  • Exp 11/18
  • T700006
  • T700014
  • T700033
  • T700035
  • T700036 12/18
  • b) T600407

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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