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Class II · ModerateRecall completed

Ramipril

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numbera) NDC [redacted-phone]; Lots G326781, exp. date 30-Sep-25, GA04468, exp. date 31-May-25 b) NDC [redacted-phone]; Lots G326763, exp. date 30-Sep-25, GA03041, exp. date 31-Mar-26, GA03725, exp. date 30-Apr-26, GA04402, exp. date 31-May-26, c) NDC [redacted-phone]; Lots G326782, exp. date 30-Sep-25, GA04462, exp. date 31-May-26
Where it was soldProduct was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited, Goa, India foreign manufacturer
Brand nameRAMIPRIL
Generic nameRAMIPRIL
Active ingredient(s)RAMIPRIL
Distributed by / forLupin Pharmaceuticals, Inc., Baltimore, MD
NDC68180-589-09
Show the full FDA record
Full product labelRamipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
Quantity112,770 bottles
Recall initiated2024-10-23
Report date2024-11-27
Recall completed2026-01-05
Recall numberD-0052-2025
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.