FDARecall 99711Medicines
What to do
The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.
Read the official notice on accessdata.fda.gov (opens in a new tab)
Hazard
Why it was recalled
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
FDA classification: Class II. Use may cause temporary or medically reversible health consequences, or the chance of serious consequences is remote. Status: Ongoing.
Is it yours? Products and codes
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 or code
- a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
- FDA recall number
- D-0831-2026
- Quantity
- a) 25,970 bottles; b) 2,384 bottles
Distribution (FDA): Nationwide within the United States
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- Hikma Pharmaceuticals USA INC.
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.