The Recall Desk
ModerateFDA (Drugs)·D-1503-2016·Announced 2016-09-28

Lupin Recalls Lisinopril Tablets Due to CGMP Deviations

Lupin Pharmaceuticals is recalling 5,880 bottles of 40 mg Lisinopril tablets because they were manufactured using active pharmaceutical ingredients that failed specifications.

What this means for you

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 a violation of CGMPs that is not likely to cause adverse health consequences. This aligns with the 'Moderate' severity level for minor labeling errors or low-risk contamination issues where no specific harm is reported.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling 5,880 bottles of Lisinopril Tablets USP, 40 mg, 1000-count bottles. The product is prescription-only and was manufactured for Lupin Pharmaceuticals, Inc. in Baltimore, MD, and manufactured by Lupin Limited in India. The specific batch number is H303449 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. This means the raw materials used to create the medication did not meet the required quality standards.

The recalled 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. Patients and healthcare providers should check their inventory for this specific batch and contact their pharmacist or physician for guidance on alternative treatment options.

The recalled product

Product
LISINOPRIL (LISINOPRIL)
Brand
LISINOPRIL
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
5,880

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 (2)

  • Batch number: H303449
  • 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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Same hazard · cgmp deviation

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