Dr. Reddy's Atorvastatin Calcium Tablets Recalled for Failed Impurity Specifications
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium Tablets USP 10 mg nationwide because certain lots contain impurities that exceeded acceptable 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: This is an FDA Class III recall involving failed manufacturing specifications and impurity detection. The source text does not report any illnesses or injuries, and the hazard is related to drug quality rather than direct patient harm. Class III recalls with no reported adverse effects typically correspond to a Moderate severity level.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles (NDC 55111-121-05) manufactured in India. The recall affects lot numbers C905064 and C905065 with expiration date 07/2021. A total of 5,984 bottles were distributed nationwide in the United States.
The recall was initiated because these lots failed impurity and degradation specifications due to the presence of ATV cyclo IP and FP impurities. The product did not meet required quality standards for pharmaceutical purity.
Patients taking this medication should not stop taking their atorvastatin without consulting their healthcare provider. Consumers with affected lots should contact Dr. Reddy's Laboratories or consult their pharmacist for further guidance. Healthcare providers and patients should report any adverse events related to this product to the FDA.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Affected units
- 5,984
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 #: C905064
- C905065
- Exp. Date 07/2021
UPCs (1)
- 0355111123903
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ATORVASTATIN CALCIUM
- ModerateAtorvastatin 10 mg tablets recalled after failing dissolution specifications
FDA (Drugs) · 2025-10-22
- ModerateAtorvastatin 40 mg tablets recalled after failing dissolution specifications
FDA (Drugs) · 2025-10-22
- ModerateAtorvastatin 20 mg tablets recalled after failing dissolution specifications
FDA (Drugs) · 2025-10-22
- ModerateAtorvastatin 80 mg tablets recalled after failing dissolution specifications
FDA (Drugs) · 2025-10-22
- HighBiocon Pharma atorvastatin calcium tablets recalled for failed dissolution specifications
FDA (Drugs) · 2025-04-09
Same manufacturer · Dr. Reddy's Laboratories, Inc.
See all →- ModerateVarenicline tablets recalled after an assay value fell below specification
FDA (Drugs) · 2025-12-17
- Moderate
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- SevereLevetiracetam Injection Label Mismatch Nationwide Recall
FDA (Drugs) · 2025-04-23
- ModerateFDA Recalls JAVYGTOR Tablets Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2024-12-18
Same hazard · impurity contamination
See all →- ModerateEnalapril Maleate 20 mg tablets recalled for out-of-specification impurities
FDA (Drugs) · 2026-05-13
- ModeratePerrigo basic+care Fexofenadine Tablets Recall—Failed Impurity Specifications
FDA (Drugs) · 2022-01-12
- ModerateCefixime 400 mg Capsules Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2022-01-12
- ModeratePerrigo Fexofenadine Hydrochloride Tablets Recall for Impurity Contamination
FDA (Drugs) · 2022-01-12
- SevereIrbesartan and Hydrochlorothiazide Tablets Recalled for Impurity Contamination
FDA (Drugs) · 2021-11-10
Similar recalls
- LowDr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities
FDA (Drugs) · 2021-06-02
- LowDr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures
FDA (Drugs) · 2018-06-27
- ModeratePrescription Atorvastatin Calcium Tablets Recalled for Failed Quality Specifications
FDA (Drugs) · 2022-04-06
- ModerateDr. Reddy's Recalls Pravastatin Sodium Tablets Due to Impurity
FDA (Drugs) · 2017-08-09
- ModerateAtorvastatin 10 mg tablets recalled after failing dissolution specifications
FDA (Drugs) · 2025-10-22
- ModerateDr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Foreign Object
FDA (Drugs) · 2018-06-27