The Recall Desk
ModerateFDA (Drugs)·D-66403-007·Announced 2013-11-13

Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

Mylan Pharmaceuticals is recalling Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

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 recall is classified as FDA Class II, which is typically associated with a temporary or medically reversible adverse health consequence. The source text cites CGMP deviations without reporting specific injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg. The affected products are packaged in 100-count bottles (NDC 0378-6897-01) and 500-count bottles (NDC 0378-6897-05). The recall involves 60,506 bottles distributed nationwide and in Puerto Rico.

The recall was initiated because the pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices (CGMP Deviations). Specific lot numbers affected include 2003169, 2003170, 2003171, 2003172, 2003173, and 3043493 for the 100-count bottles, and 2003168, 2003169, and 3043493 for the 500-count bottles.

Consumers and healthcare providers should check their inventory for these specific NDCs and lot numbers. Patients should contact their healthcare provider or pharmacist for guidance on alternative treatments or further instructions regarding the recalled medication.

The recalled product

Product
Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6897-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
60,506

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 (8)

  • Lot #: a) 2003169
  • 2003170
  • 2003171
  • 2003172
  • 2003173
  • 3043493
  • b) 2003168
  • 2003169

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 12 recalled by Mylan Pharmaceuticals 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 12 products in this recall →

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