Agency classClass IIOur severity:Severe FDA (Drugs)·D-66403-008·Announced 2013-11-13

Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

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

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 per the rubric corresponds to a severity score of 4 (Severe) when associated with significant injury or property damage reports, or generally high-risk scenarios involving medication efficacy/safety deviations.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling 11,701 bottles of Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles. The affected product is prescription-only and is identified by NDC 0378-6899-01. The recall covers lots 2003184, 2003185, 2003186, and 3043495.

The recall was initiated because the pharmaceuticals were produced and distributed with active ingredients that were not manufactured according to Good Manufacturing Practices (CGMP Deviations). This classification indicates a potential risk that the medication may not be safe or effective.

The affected products were distributed nationwide and in Puerto Rico. Patients who have this medication should contact their healthcare provider or pharmacist for guidance on whether to continue taking the medication or to obtain a replacement.

The recalled product

Product: Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6899-01
Manufacturer: Mylan Pharmaceuticals Inc.
Category: Drug — Prescription Medication
Hazard: manufacturing-deviation
medication-efficacy
Affected units: 11,701

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 (4)

Lot #: 2003184
2003185
2003186
3043495

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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