FDAClass II · Drug · Recall D-0831-2026 · Recalled September 2, 2026

Ramipril Capsules USP recall — Hikma Pharmaceuticals USA INC.

Agency report date: September 2, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Ramipril Capsules USP
Company / brand: Hikma Pharmaceuticals USA
Lot / serial / date codes: a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
Distribution: Nationwide within the United States

Agency product description and boundaries

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.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Ramipril Capsules USP recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0831-2026
Brand: All Hikma Pharmaceuticals USA recalls
Classification: Class II
Units affected: a) 25,970 bottles; b) 2,384 bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Ramipril Capsules USP recall status

Companies & origin

Recalling firm location: Columbus, OH, United States
Firm address: 1809 Wilson Rd, N/A, 43228-9579

Identifying details (verbatim from the notice)

Product codes / lots: a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
Distribution: Nationwide within the United States
Firm notified the public via: Letter
FDA event ID: 99711
Recall initiated: August 24, 2026
FDA classified: September 3, 2026
FDA report date: September 2, 2026

Other drug recalls from around the same time

Glutathione 200 mg/mL recall — OPTIMAL BALANCE PHARMACYFDA · September 9, 2026
0 recall — Baxter Healthcare CorporationFDA · September 9, 2026
Lactated Ringer's Injection USP recall — B BRAUN MEDICAL INCFDA · September 2, 2026
Tyenne (tocilizumab-aazg) Injection recall — Fresenius Kabi USA, LLCFDA · September 2, 2026
Papaverine HCl Injection recall — American Regent, Inc.FDA · August 26, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

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