The Recall Desk
ModerateFDA (Drugs)·D-1373-2015·Announced 2015-09-02

Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

Dr. Reddy's Laboratories is recalling 1,056 bottles of 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 unlikely to cause adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a direct safety hazard like contamination or injury.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling 1,056 bottles of Amlodipine Besylate and Atorvastatin Calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles. The product is a prescription-only medication manufactured by Dr. Reddy's Laboratories Limited in India. The specific lot number is C403575, with an expiration date of 10/2015.

The recall was initiated because the atorvastatin component in the tablets is subpotent, meaning it does not contain the full labeled amount of the active ingredient. This condition may result in patients not receiving the intended therapeutic effect from the medication.

The affected product was distributed nationwide in the United States. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The FDA has classified this recall as Class III, indicating that use of or exposure to the product 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
Affected units
1,056

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 (2)

  • Lot #: C403575
  • Expiry: 10/2015

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

Same manufacturer · Dr. Reddy's Laboratories, Inc.

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Same hazard · subpotent drug

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