The Recall Desk
HighFDA (Drugs)·D-0054-2025·Announced 2024-11-27

Ramipril Capsule Medication Recalled Over Unapproved Vendor Manufacturing Deviations

Lupin Pharmaceuticals is recalling 357,414 bottles of Ramipril 10 mg capsules due to CGMP deviations where the active pharmaceutical ingredient was sourced from an unapproved vendor. The affected product was distributed to 30 wholesalers with potential nationwide distribution.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for CGMP deviations involving unapproved sourcing of the active pharmaceutical ingredient in a blood pressure medication, which presents a risk of harm to patients relying on this drug. No illnesses or injuries have been reported, limiting the severity below Class II recalls with hospitalization reports.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Ramipril Capsules USP 10 mg due to manufacturing deviations. The recall affects 357,414 bottles in three package sizes: 90-count (NDC 68180-591-09), 100-count (NDC 68180-591-01), and 500-count (NDC 68180-591-02) bottles.

The FDA issued this Class II recall because the active pharmaceutical ingredient was sourced from an unapproved vendor. This manufacturing practice deviation raises quality control concerns for the affected medication.

The product was distributed to 30 wholesalers and distributors nationwide. Multiple lot numbers are affected with varying expiration dates, detailed in the FDA recall notice.

Consumers in possession of affected bottles should verify the lot number and expiration date against the FDA recall list. For guidance on replacement medication, patients should contact their healthcare provider or pharmacist.

The recalled product

Product
RAMIPRIL (RAMIPRIL)
Brand
RAMIPRIL
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug
Hazard
Affected units
357,414

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 (17)

  • a) NDC 68180-591-09
  • Lots G327086
  • exp. date 30-Sep-25 GA01065
  • exp. date 31-Dec-25
  • b) NDC 68180-591-01 Lots G325033
  • G324987
  • exp. date 31-Jul-25
  • G325110
  • GA00956
  • GA01066
  • GA01126
  • GA03299
  • GA03288
  • GA03287
  • exp. date 31-Mar-26 c) NDC 68180-591-02 Lot GA05919
  • exp. date 31-Jul-26 G327131
  • exp. date 30-Sep-25

UPCs (3)

  • 0368180591092
  • 0368180589099
  • 0368180590095

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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