The Recall Desk
ModerateFDA (Drugs)·D-0819-2018·Announced 2018-05-23

Mylan Recalls Amlodipine and Benazapril Capsules Due to Cleaning Deviations

Mylan Pharmaceuticals is recalling specific lots of Amlodipine and Benazapril HCL Capsules because the cleaning process for manufacturing equipment was not followed according to procedure.

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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a procedural deviation (cleaning process) without reported harm, fitting the criteria for a moderate severity score.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling 25,488 bottles of Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles (NDC 0378-6896-01). The affected lot numbers are 3083005, 3083006, 3086121, and 3086122, all with an expiration date of January 2019.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations. Specifically, the cleaning process for the equipment used to manufacture these specified batches was not followed according to procedure. The product was distributed throughout the United States.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations.

The recalled product

Product
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
25,488

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 (5)

  • Lot Numbers# 3083005
  • 3083006
  • 3086121
  • and 3086122
  • 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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