The Recall Desk
SevereFDA (Drugs)·D-66403-009·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

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' severity score according to the rubric, as it involves a reasonable probability of temporary or medically reversible adverse health consequences.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count and 500 count bottles. The recall involves 42,174 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). The affected lots include 2003177, 2003178, 2003179, 2003180, 3043496, 2003176, and 3043496.

Consumers should stop using the recalled medication and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is classified as FDA Class II.

The recalled product

Product
Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.***
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
42,174

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 (7)

  • Lot #: a) 2003177
  • 2003178
  • 2003179
  • 2003180
  • 3043496
  • b) 2003176
  • 2003177

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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