The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1493-2016·Announced 2016-09-14

Lupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients that failed specifications.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 III, which indicates the product is not likely to cause adverse health consequences. The hazard involves CGMP deviations regarding ingredient specifications, which fits the criteria for a moderate severity voluntary precautionary recall without reported illness.

Plain-English summary

Lupin Limited is recalling Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles. The recall involves 11,812 bottles of the prescription medication, which is manufactured for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland, and manufactured by Lupin Limited in Goa, India.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the finished products were manufactured using active pharmaceutical ingredients whose intermediates failed specifications. The affected lots include G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, and G304534, all with an expiration date of 4/2016.

The recalled product was distributed in the United States. No recalled product was distributed to any foreign consignees by Lupin. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description.

The recalled product

Product
AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
Brand
AMLODIPINE BESYLATE
Manufacturer
Lupin Limited
Category
Drug — Prescription Medication
Hazard
Affected units
11,812

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 (13)

  • Lot #: G304677
  • G304540
  • G304536
  • G304537
  • G304535
  • G304541
  • G304545
  • G304533
  • G304532
  • G304539
  • G304538
  • G304534
  • Exp. 4/2016

UPCs (1)

  • 0368180233022

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Lupin Limited 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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