CLASS II Drug recall · Reported 4 Jul 2012 · FDA Enforcement Report
Nisoldipine Extended Release Tablets, 17mg recalled by Shionogi
Shionogi is recalling Nisoldipine Extended Release Tablets, 17mg, distributed in Pennsylvania. The recall was initiated on 8 Mar 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1398-2012
- FDA event ID
- 62004
- Recalling firm
- Shionogi, Alpharetta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Mar 2012
- FDA classified
- 26 Jun 2012
- Reported
- 4 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 8 Mar 2012 | Recall initiated by company | |
| 26 Jun 2012 | Classified by FDA | +110 days |
| 4 Jul 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
PA
Questions about this recall
Is Nisoldipine Extended Release Tablets, 17mg recalled?
Yes. Shionogi recalled Nisoldipine Extended Release Tablets, 17mg on 8 Mar 2012. The recall is Class II and its status is Terminated. Recall number D-1398-2012.
Why was it recalled?
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Which lots are affected?
Lot number: 2021956, Exp; 01/2013
Where was it sold?
PA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Shionogi
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Mefenamic Acid Capsules, USP, 250 mg recalled by Shionogi | Shionogi | Particulate Matter | Nationwide |
| Drug | CLASS III | Mefenamic Acid, 250mg capsules recalled by Shionogi | Shionogi | Potency & Assay | Nationwide |
| Drug | CLASS III | Ponstel (Mefanamic Acid) recalled by Shionogi | Shionogi | Potency & Assay | Nationwide |
| Drug | CLASS III | Nisoldipine Extended Release Tablets, 17 mg recalled by ShionogiNisoldipine | Shionogi | Potency & Assay | Nationwide |
Other Nisoldipine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nisoldipine Extended Release Tablets, 17 mg recalled by ShionogiNisoldipine | Shionogi | Potency & Assay | Nationwide |