The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1378-2015·Announced 2015-09-02

Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

Dr. Reddy's is recalling specific lots of Amlodipine Besylate and Atorvastatin Calcium tablets because they contain subpotent atorvastatin.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Amlodipine Besylate and Atorvastatin Calcium Tablets, 10 mg/40 mg, due to the presence of subpotent atorvastatin. The affected products are packaged in 30-count and 90-count bottles and were distributed nationwide in the United States.

The recall involves specific lots: C409650 and C409652, both with an expiration date of 05/2016. The total quantity recalled is 16,848 bottles of the 30-count size and 216 bottles of the 90-count size. The agency has classified this as a Class III recall, indicating that the violation is not likely to cause adverse health consequences.

Consumers with these specific lot numbers should stop using the medication and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The product is a prescription-only medication manufactured by Dr. Reddy's Laboratories Limited in India.

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 (4)

  • a) Lot #: C409650
  • Expiry: 05/2016
  • Lot #: C409652
  • Expiry: 05/2016. b) Lot #: C409652

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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