The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1468-2016·Announced 2016-08-31

Mylan Amlodipine Tablets Recalled for CGMP Deviations

Mylan Institutional is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients 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, and the rubric specifies that FDA Class II recalls with potential for serious adverse health consequences (implied by CGMP deviations in active ingredients) align with a Severe rating, particularly when no specific lower-risk classification is provided.

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Amlodipine Besylate Tablets, USP, 10 mg. The recall involves specific lot numbers of 100-count, 300-count, and 25-count unit dose blisters and Robot-Rx Ready Packages. The affected products were distributed nationwide, as well as in Puerto Rico and Guam.

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 of serious adverse health consequences or death, though the source text does not specify reported illnesses or injuries.

Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or the recalling firm for instructions on returns or replacements. The specific lot numbers and expiration dates are listed in the structured product information.

The recalled product

Product
Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19…
Manufacturer
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Category
Drug — Prescription Medication
Hazard

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 (9)

  • Lot #: a) 3039795
  • 3042896
  • Exp 04/14
  • b) 3039793
  • 3042892
  • c) 2120054
  • Exp 02/14
  • 2120090
  • Exp 05/14

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 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 3 products in this recall →

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