Shionogi Recalls Nisoldipine Extended Release Tablets for Dissolution Failure
Shionogi Inc. is recalling Nisoldipine Extended Release Tablets, 17mg, because a specific lot failed USP dissolution testing requirements.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The specific defect is a dissolution failure, which is a quality control issue rather than a direct contamination or acute hazard like a high-risk pathogen or structural defect.
Plain-English summary
Shionogi Inc. is recalling Nisoldipine Extended Release Tablets, 17mg, 100 count bottles. The recall involves 7,230 bottles of the prescription medication, which is manufactured for Prasco Laboratories and manufactured by SkyePharma production SAS. The specific lot number is 2021956, with an expiration date of 01/2013.
The recall was initiated because the product failed USP Dissolution Test Requirements, specifically resulting in an out-of-specification dissolution result at the 18-month time point. This indicates that the tablets may not release the medication at the intended rate.
The affected product was distributed in Pennsylvania. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund.
The recalled product
- Product
- Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01
- Manufacturer
- Shionogi Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 7,230
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 (3)
- Lot number: 2021956
- Exp
- 01/2013
Distribution
Distributed in 1 state:
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