The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1502-2016·Announced 2016-09-28

Lupin Recalls Lisinopril Tablets Due to CGMP Deviations

Lupin Pharmaceuticals is recalling 20,556 bottles of Lisinopril 30 mg tablets because they were manufactured using active pharmaceutical ingredients whose intermediates 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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as a situation where use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling 20,556 bottles of Lisinopril Tablets USP, 30 mg. The affected product is packaged in 500-count bottles (NDC 68180-516-02) and 100-count bottles (NDC 68180-516-01). The specific batch numbers involved are H303487, H303488, and H303489, all with an expiration date of 09/16.

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 product was distributed domestically in the United States. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin, and no recalled product was distributed to any foreign consignees by Lupin.

Consumers and healthcare providers should check their inventory for the specific NDCs and batch numbers listed above. If the product is found, it should be returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative medication options if they are currently using the recalled product.

The recalled product

Product
LISINOPRIL (LISINOPRIL)
Brand
LISINOPRIL
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
20,556

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)

  • Batch number: H303487
  • H303488
  • H303489
  • Exp 09/16

UPCs (3)

  • 0368180513018
  • 0368180512028
  • 0368180513032

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Lupin 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 2 products in this recall →

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