Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported August 12, 2015
Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH 45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.
Failed Dissolution Specifications
Shionogi Inc. recalled Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended… - a low-severity action.
Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended… was recalled by Shionogi Inc. in August 12, 2015. Reason: Failed Dissolution Specifications. Check the official notice for the remedy. Verify recall #D-1284-2015 with the FDA Drug before acting.
The recall
Shionogi Inc. issued this low-severity FDA Drug recall-Failed Dissolution Specifications.
- Low
- severity level
- Class III
- classification
- August 12, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1284-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1284-2015) was formally reported on August 12, 2015, with the manufacturer initiating the action on July 24, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Shionogi Inc. is listed as the recalling firm, operating out of Alpharetta, GA. Federal records list the affected scope as a) 483 bottles; b) 5,631 bottles.
The documented reason for this recall is: Failed Dissolution Specifications Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
a) 483 bottles; b) 5,631 bottles
Related Recalls
6
0 from same agency
Product description
Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH 45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.
Reason for recall
Failed Dissolution Specifications
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1284-2015 |
| Date reported | August 12, 2015 |
| Date initiated | July 24, 2015 |
| Recalling firm | Shionogi Inc. |
| Firm location | Alpharetta, GA |
| Affected scope | a) 483 bottles; b) 5,631 bottles |
| Distribution | Nationwide and Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1284-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH 45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.. Recalled by Shionogi Inc.. Units affected: a) 483 bottles; b) 5,631 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 12, 2015. Severity: Low. Recall number: D-1284-2015.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1284-2015) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported August 12, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.