The Recall Desk
SevereFDA (Drugs)·D-1434-2012·Announced 2012-08-08

Dr. Reddy's Recalls Amlodipine and Benazepril Capsules Due to Foreign Tablets

Dr. Reddy's is recalling Amlodipine Besylate and Benazepril Hydrochloride capsules because bottles were mislabeled and contained foreign Ciprofloxacin tablets.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of patients ingesting the wrong medication (Ciprofloxacin instead of Amlodipine/Benazepril).

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling 1,656 bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules (5 mg/20 mg). The recall is due to complaints that the bottles were mislabeled and contained foreign Ciprofloxacin tablets.

The affected product is manufactured by Dr. Reddy's Laboratories Limited in India and distributed nationwide and in Puerto Rico. The specific lot number is C201293 with an expiration date of 08/2013.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement medication.

The recalled product

Product
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE)
Brand
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Affected units
1,656

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)

  • C201293 Exp Date 08/2013

UPCs (2)

  • 0355111339014
  • 0355111340010

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same brand · AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE