The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-66403-010·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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While specific injury reports are not detailed in the snippet, the CGMP deviation regarding active ingredients in a prescription drug carries a significant risk of harm, aligning with the Severe criteria for Class II drug recalls.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling 23,356 bottles of Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles. The affected products are prescription-only and were distributed nationwide and in Puerto Rico. The recall involves specific lot numbers: 2003188, 2003189, 2003190, 2003191, and 3043498.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The source text states that the pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. This classification indicates a potential risk that the medication may not be safe, effective, or of the quality it is supposed to be.

Consumers and healthcare providers should check their inventory for the specific NDC 0378-6900-01 and the listed lot numbers. If the product matches the recalled description, it should be returned to the pharmacy or supplier for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they are currently using this medication.

The recalled product

Product
Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
23,356

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 #: 2003188
  • 2003189
  • 2003190
  • 2003191
  • 3043498

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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