Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bott
Summary
The FDA issued a Class II for Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and by Hikma Pharmaceuticals USA INC.. Reason: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU)..
Details
Source
Drug Recall
External ID
D-0831-2026
Action Date
2026-09-02
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
Quantity Affected: a) 25,970 bottles; b) 2,384 bottles
Reason for Recall
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-24
Company
Columbus, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 38 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Hikma Pharmaceuticals USA INC. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hikma Pharmaceuticals USA INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hikma Pharmaceuticals USA INC. have FDA actions?
Hikma Pharmaceuticals USA INC. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0831-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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