The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0820-2018·Announced 2018-05-23

Mylan Recalls Amlodipine and Benazapril Capsules Due to Cleaning Deviations

Mylan Pharmaceuticals is recalling Amlodipine and Benazapril HCL Capsules because cleaning processes for manufacturing equipment were not followed according to procedure.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a procedural deviation (cleaning) without reported harm, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Mylan Pharmaceuticals, Inc. is recalling Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles (NDC 0378-6899-01). The recall involves 12,924 bottles with Lot Numbers 3083008 and 3086124, which have an expiration date of January 2019.

The recall was initiated because cleaning processes for the equipment used to manufacture the specified batches were not followed according to procedure, resulting in cGMP deviations. The product was distributed throughout the United States.

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

The recalled product

Product
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
12,924

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 Numbers# 3083008 and 3086124
  • exp Jan 2019

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

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

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