Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported September 26, 2018
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Torrent Pharma Inc. recalled Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufa… - a moderate-severity action.
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufa… was recalled by Torrent Pharma Inc. in September 26, 2018. Reason: Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour tim…. Check the official notice for the remedy. Verify recall #D-1204-2018 with the FDA Drug before acting.
The recall
Torrent Pharma Inc. issued this moderate-severity FDA Drug recall-Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour tim….
- Moderate
- severity level
- Class II
- classification
- September 26, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1204-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1204-2018) was formally reported on September 26, 2018, with the manufacturer initiating the action on September 11, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Torrent Pharma Inc. is listed as the recalling firm, operating out of Kalamazoo, MI. Federal records list the affected scope as 15,384 30-count bottles.
The documented reason for this recall is: Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing. Distribution data in the federal record shows the product reached: Nationwide USA. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
15,384 30-count bottles
Related Recalls
6
0 from same agency
Product description
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30
Reason for recall
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1204-2018 |
| Date reported | September 26, 2018 |
| Date initiated | September 11, 2018 |
| Recalling firm | Torrent Pharma Inc. |
| Firm location | Kalamazoo, MI |
| Affected scope | 15,384 30-count bottles |
| Distribution | Nationwide USA |
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-1204-2018) 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? ▼
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30. Recalled by Torrent Pharma Inc.. Units affected: 15,384 30-count bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 26, 2018. Severity: Moderate. Recall number: D-1204-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1204-2018) 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.
CPSC Moderate
AMASKY Nursing Pillows Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards fo…
Xishentang Dongguan Trading Co, Ltd., dba Pretty-Life, of China · 2026-07-02
CPSC Moderate
Diamond Wipes International Recalls CVS Health Medicated Hemorrhoidal Wipes Due to Risk of Serious Injury or Death from…
Diamond Wipes International, Inc. of Chino, California · 2026-07-02
CPSC Moderate
Junpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; V…
· 2026-07-02
CPSC Moderate
Target Recalls Gigglescape™ Under the Sea Popping Toy Due to Choking Hazard
· 2026-07-02
CPSC Moderate
Vevor Recalls Baby Loungers Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violate Mandatory …
Sanven Technology Ltd., dba Vevor, of Rancho Cucamonga, California · 2026-07-02
Compare this recall with AMASKY Nursing Pillows Recalled Due to Risk of Serious Inju… →
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 26, 2018. 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.