Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported September 23, 2015
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Novartis Pharmaceuticals Corp. recalled Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufact… - a low-severity action.
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufact… was recalled by Novartis Pharmaceuticals Corp. in September 23, 2015. Reason: Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification…. Check the official notice for the remedy. Verify recall #D-1430-2015 with the FDA Drug before acting.
The recall
Novartis Pharmaceuticals Corp. issued this low-severity FDA Drug recall-Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification….
- Low
- severity level
- Class III
- classification
- September 23, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1430-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1430-2015) was formally reported on September 23, 2015, with the manufacturer initiating the action on July 28, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Novartis Pharmaceuticals Corp. is listed as the recalling firm, operating out of Suffern, NY. Federal records list the affected scope as 10,767 bottles.
The documented reason for this recall is: Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing. Distribution data in the federal record shows the product reached: NJ - site for distributor. 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, 5 from FDA Drug - 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.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications 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
10,767 bottles
Related Recalls
6
5 from same agency
Product description
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Reason for recall
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1430-2015 |
| Date reported | September 23, 2015 |
| Date initiated | July 28, 2015 |
| Recalling firm | Novartis Pharmaceuticals Corp. |
| Firm location | Suffern, NY |
| Affected scope | 10,767 bottles |
| Distribution | NJ - site for distributor |
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-1430-2015) 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? ▼
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540. Recalled by Novartis Pharmaceuticals Corp.. Units affected: 10,767 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 23, 2015. Severity: Low. Recall number: D-1430-2015.
Where was the recalled product distributed? ▼
Distribution: NJ - site for distributor.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1430-2015) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
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 September 23, 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.