Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
Dr. Reddy's Laboratories is recalling Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component is subpotent.
What this means for you
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 FDA classified this as a Class III recall, which is defined as a violation not likely to cause adverse health consequences. This aligns with the rubric for moderate severity involving minor labeling or quality errors without reported harm.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Amlodipine Besylate and Atorvastatin Calcium Tablets, 10 mg/20 mg, due to subpotent atorvastatin. The affected product is packaged in 30-count and 90-count bottles and is available by prescription only. The specific lot number is C404592 with an expiration date of 11/2015.
The recall covers 16,080 bottles of the 30-count package and 480 bottles of the 90-count package. These products were distributed nationwide in the United States. The tablets were manufactured by Dr. Reddy's Laboratories Limited in India.
Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The FDA has classified this recall as Class III, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
- Brand
- AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
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)
- a) Lot #: C404592
- Expiry: 11/2015. b) Lot #: C404592
- Expiry: 11/2015
UPCs (9)
- 0343598323305
- 0343598315300
- 0343598320304
- 0343598317304
- 0343598313306
- 0343598322308
- 0343598319308
- 0343598316307
- 0343598314303
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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 7 products in this recall →Related recalls
Same brand · AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
- LowDr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
FDA (Drugs) · 2015-09-02
- LowDr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
FDA (Drugs) · 2015-09-02
- ModerateDr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
FDA (Drugs) · 2015-09-02
- LowDr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
FDA (Drugs) · 2015-09-02
- LowDr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets
FDA (Drugs) · 2015-09-02
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 · subpotent drug
See all →- ModerateAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02