The Recall Desk
HighFDA (Drugs)·D-0052-2025·Announced 2024-11-27

FDA recalls Ramipril 2.5 mg capsules for manufacturing control deviations

Lupin Pharmaceuticals is recalling Ramipril 2.5 mg capsules after sourcing the active ingredient from an unapproved vendor. Approximately 112,770 bottles were distributed to wholesalers nationwide.

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: Although classified as FDA Class II, this recall involves no reported illnesses, injuries, or hospitalizations. The hazard—a manufacturing control deviation involving unapproved ingredient sourcing—represents potential risk to drug quality rather than documented harm. Per the rubric, risk-of-harm products without reported injury score 3 (High).

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Ramipril Capsules USP 2.5 mg in three bottle sizes: 90-count (NDC 68180-589-09), 100-count (NDC 68180-589-01), and 500-count (NDC 68180-589-02). Approximately 112,770 bottles were distributed to approximately 30 wholesalers and distributors who may have further distributed the product nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the active pharmaceutical ingredient (ramipril) was sourced from a vendor that has not been approved by Lupin Pharmaceuticals or the FDA.

The affected lots include: NDC 68180-589-09 lots G326781 (expires 30-Sep-25) and GA04468 (expires 31-May-25); NDC 68180-589-01 lots G326763 (expires 30-Sep-25), GA03041 (expires 31-Mar-26), GA03725 (expires 30-Apr-26), and GA04402 (expires 31-May-26); NDC 68180-589-02 lots G326782 (expires 30-Sep-25) and GA04462 (expires 31-May-26).

Consumers who have received this medication should check the lot number and expiration date on their prescription bottle. Patients should contact their pharmacy or healthcare provider if they have this medication. Do not stop taking any prescribed medication without consulting your healthcare provider.

The recalled product

Product
RAMIPRIL (RAMIPRIL)
Brand
RAMIPRIL
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — ACE Inhibitor
Hazard
  • manufacturing-deviation
  • unapproved-ingredient-source

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 (15)

  • a) NDC 68180-589-09
  • Lots G326781
  • exp. date 30-Sep-25
  • GA04468
  • exp. date 31-May-25 b) NDC 68180-589-01
  • Lots G326763
  • GA03041
  • exp. date 31-Mar-26
  • GA03725
  • exp. date 30-Apr-26
  • GA04402
  • exp. date 31-May-26
  • c) NDC 68180-589-02
  • Lots G326782
  • GA04462

UPCs (3)

  • 0368180591092
  • 0368180589099
  • 0368180590095

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · RAMIPRIL

Same category