Prescription Atorvastatin Calcium Tablets Recalled for Failed Quality Specifications
Dr. Reddy's Laboratories is recalling 28,068 bottles of Atorvastatin Calcium 80 mg tablets nationwide due to failed impurity and degradation specifications. No illnesses or injuries have been reported.
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: This is an FDA Class III recall with no reported illnesses or injuries. The manufacturing quality issue involves impurities and degradation that failed specifications, representing a precautionary recall without evidence of actual patient harm.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Atorvastatin Calcium tablets, 80 mg strength, in bottles of 90 tablets. Approximately 28,068 bottles were distributed nationwide in the United States.
The recall was initiated because certain lots failed to meet specifications for related substance impurities and degradation. The affected lots are: T000707, T000756, T000758, T000759 (expiration 03/2022); T2100600, T2101075 (expiration 1/2023); and T2102802 (expiration 07/2023).
Atorvastatin Calcium is a prescription medication used to lower cholesterol. Patients taking this medication from the affected lots should contact their healthcare provider or pharmacist for guidance. They should not discontinue the medication without consulting their healthcare provider first. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Generic Statin
- Hazard
- Affected units
- 28,068
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 (10)
- Lot: T000707
- T000756
- T000758
- T000759
- Exp 03/2022
- T2100600
- T2101075
- Exp. 1/2023
- T2102802
- Exp. 07/2023
Distribution
Distributed nationwide across the United States.
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