Pharmedium Recalls All Nicardipine HCl Due to Sterility Assurance Issues
Pharmedium Services, LLC is recalling all lots of Nicardipine HCl because the product lacks sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in a drug product warrants a score of 4 (Severe), as it poses a risk of temporary or medically reversible health consequences.
Plain-English summary
Pharmedium Services, LLC is recalling all lots of Nicardipine HCl in all strengths, doses, and packaging. The recall is being conducted because the product lacks sterility assurance. The affected products were distributed nationwide in the United States.
The recall includes all lots remaining within their expiry dates. No specific lot numbers or quantities are provided in the source text. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the recalled Nicardipine HCl products and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.
The recalled product
- Product
- Nicardipine HCl in all strengths, all doses, and all packaging.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Hazard
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 (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
Same manufacturer · Pharmedium Services, LLC
See all →- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Phenylephrine Injection Due to Sterility Assurance Failure
FDA (Drugs) · 2018-02-21
- ModerateNicardipine Hydrochloride Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2024-05-29
- SeverePharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- SeverePharmedium Recalls Ketamine HCl Injection Due to Potential Loss of Potency
FDA (Drugs) · 2016-10-19
- SeverePharmedium Recalls Lidocaine Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19