Agency classClass IIOur severity:Moderate FDA (Drugs)·D-66403-006·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.

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, and the hazard is a manufacturing deviation rather than a confirmed contamination or defect causing harm.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, in 100-count and 500-count bottles. The recall involves 30,878 bottles distributed nationwide and in Puerto Rico.

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). The affected lot numbers are 2003159, 2003160, 2003161, 3043492 for 100-count bottles, and 2003158, 2003159, 3043492 for 500-count bottles.

Consumers should check their medication bottles for the NDC codes 0378-6896-01 or 0378-6896-05 and the specific lot numbers listed above. If the medication matches the recalled product, patients should contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.

The recalled product

Product: Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Manufacturer: Mylan Pharmaceuticals Inc.
Category: Drug — Prescription Medication
Hazard: cgmp-deviation
manufacturing-error
Affected units: 30,878

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 (6)

Lot #: a) 2003159
2003160
2003161
3043492
b) 2003158
2003159

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 →

Same manufacturer · Mylan Pharmaceuticals Inc.

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Same hazard · cgmp deviation