The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0831-2026·Announced 2026-09-02

Hikma Recalls Ramipril Capsules Due to Process Impurity

Hikma Pharmaceuticals is recalling specific lots of Ramipril 10 mg capsules because they failed impurity specifications for dicyclohexylurea.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

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 II, which typically corresponds to a Moderate severity score (2) in the absence of reported hospitalizations or significant injuries, as the hazard is a process impurity failure without reported adverse health consequences.

Plain-English summary

Hikma Pharmaceuticals USA INC. is recalling Ramipril Capsules USP, 10 mg, manufactured for Exelan Pharmaceuticals, Inc. The affected products are packaged in bottles of 100 capsules (NDC 76282-673-01) and 500 capsules (NDC 76282-673-05). The recall involves Lot AC5470A and Lot AC5470B, both with an expiration date of July 2027. A total of 25,970 bottles of the 100-capsule size and 2,384 bottles of the 500-capsule size are affected.

The recall was initiated because the product failed impurities/degradation specifications. Specifically, an out-of-specification (OOS) result was obtained for a process impurity known as dicyclohexylurea (DCU). The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected products were distributed nationwide within the United States. Consumers and healthcare providers should check their inventory for the specific NDC numbers, lot numbers, and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
RAMIPRIL (RAMIPRIL)
Brand
RAMIPRIL
Manufacturer
Hikma Pharmaceuticals USA INC.
Category
Drug — Prescription Drug
Hazard

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 (3)

  • a) Lot #: AC5470A
  • Exp. Date July 2027 b) Lot #: AC5470B
  • Exp. Date July 2027

UPCs (3)

  • 0376282670010
  • 0376282672014
  • 0376282673011

Distribution

Distributed nationwide across the United States.

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