Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures
Dr. Reddy's is recalling 40 mg Atorvastatin Calcium tablets because stability testing showed impurity levels exceeding 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 unlikely to cause adverse health consequences. The issue is a failure of impurity specifications without reported injuries.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 2,280 bottles of Atorvastatin Calcium tablets, 40 mg, 500-count. The affected product is identified by NDC 55111-123-05 and code T60045. The recall covers distribution across the United States.
The recall was initiated because out-of-specification (OOS) results were observed for ATV Cyclo FP Impurity and Total Degradation Impurities during testing at the 18-month stability time point. This indicates the product failed to meet established impurity and degradation specifications.
Consumers and healthcare providers with this specific product should stop using it and contact their pharmacist or Dr. Reddy's Laboratories for instructions on return or replacement.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 2,280
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 (1)
- T60045
UPCs (1)
- 0355111123903
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ATORVASTATIN CALCIUM
- ModerateAtorvastatin 80 mg tablets recalled after failing dissolution specifications
FDA (Drugs) · 2025-10-22
- 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
- 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
See all →- ModerateAjanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2026-09-16
- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
Similar recalls
- LowDr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures
FDA (Drugs) · 2018-02-07
- ModerateDr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities
FDA (Drugs) · 2018-06-27
- ModerateDr. Reddy's Atorvastatin Calcium Tablets Recalled for Failed Impurity Specifications
FDA (Drugs) · 2021-06-23
- ModeratePrescription Atorvastatin Calcium Tablets Recalled for Failed Quality Specifications
FDA (Drugs) · 2022-04-06
- ModerateDr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Foreign Object
FDA (Drugs) · 2018-06-27
- ModerateDr. Reddy's Recalls Pravastatin Sodium Tablets Due to Impurity
FDA (Drugs) · 2017-08-09