[pending] NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0399-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
The recalled product
- Product
- NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Drugs
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 (8)
- Lots
- expiry: Lot 24086N0C0
- 7/31/2025
- Lot 24076N0C0
- Lot 24090N0C0
- 8/31/2025
- Lot 25011N0C0
- 6/30/2026
Distribution
Distributed nationwide across the United States.
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- HighNicardipine Hydrochloride Injection Recalled Due to Out-of-Specification Organic Impurities
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