August 2026 FDA Recall Ramipril by Hikma Pharmaceuticals Usa Inc.
D-0831-2026 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Hikma Pharmaceuticals Usa Inc. on August 24, 2026 for the product Ramipril. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0831-2026

Reason for Recall
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Initiated
08-24-2026
Reported
09-02-2026
Quantity
a) 25,970 bottles; b) 2,384 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99711
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hikma Pharmaceuticals USA INC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

76282-670-01 Ramipril
76282-671-01 Ramipril
76282-671-05 Ramipril
76282-672-01 Ramipril
76282-672-05 Ramipril
76282-673-01 Ramipril
76282-673-05 Ramipril