Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported December 28, 2016
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Impax Laboratories, Inc. recalled Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing… - a critical-severity action.
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing… was recalled by Impax Laboratories, Inc. in December 28, 2016. Reason: Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs. Check the official notice for the remedy. Verify recall #D-0215-2017 with the FDA Drug before acting.
The recall
Impax Laboratories, Inc. issued this critical-severity FDA Drug recall-Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs.
- Critical
- severity level
- Class I
- classification
- December 28, 2016
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0215-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0215-2017) was formally reported on December 28, 2016, with the manufacturer initiating the action on August 19, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. Impax Laboratories, Inc. is listed as the recalling firm, operating out of Hayward, CA. Federal records list the affected scope as 3,074 boxes (30 count boxes).
The documented reason for this recall is: Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs Distribution data in the federal record shows the product reached: Distributed Nationwide. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,074 boxes (30 count boxes)
Related Recalls
6
5 from same agency
Product description
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
Reason for recall
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0215-2017 |
| Date reported | December 28, 2016 |
| Date initiated | August 19, 2016 |
| Recalling firm | Impax Laboratories, Inc. |
| Firm location | Hayward, CA |
| Affected scope | 3,074 boxes (30 count boxes) |
| Distribution | Distributed Nationwide |
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-0215-2017) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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 Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA. Recalled by Impax Laboratories, Inc.. Units affected: 3,074 boxes (30 count boxes).
Why was this product recalled? ▼
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 28, 2016. Severity: Critical. Recall number: D-0215-2017.
Where was the recalled product distributed? ▼
Distribution: Distributed Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0215-2017) 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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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 December 28, 2016. 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.