Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported February 19, 2020
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Taro Pharmaceuticals U.S.A., Inc. recalled Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutica… - a critical-severity action.
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutica… was recalled by Taro Pharmaceuticals U.S.A., Inc. in February 19, 2020. Reason: Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.. Check the official notice for the remedy. Verify recall #D-0833-2020 with the FDA Drug before acting.
The recall
Taro Pharmaceuticals U.S.A., Inc. issued this critical-severity FDA Drug recall-Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate..
- Critical
- severity level
- Class I
- classification
- February 19, 2020
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0833-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0833-2020) was formally reported on February 19, 2020, with the manufacturer initiating the action on December 20, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Taro Pharmaceuticals U.S.A., Inc. is listed as the recalling firm, operating out of Hawthorne, NY. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. Distribution data in the federal record shows the product reached: Nationwide in the U.S. 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, 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
Unknown
Related Recalls
6
5 from same agency
Product description
Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.
Reason for recall
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0833-2020 |
| Date reported | February 19, 2020 |
| Date initiated | December 20, 2019 |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc. |
| Firm location | Hawthorne, NY |
| Affected scope | Not disclosed |
| Distribution | Nationwide in the U.S. 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-0833-2020) 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 Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1.. Recalled by Taro Pharmaceuticals U.S.A., Inc..
Why was this product recalled? ▼
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 19, 2020. Severity: Critical. Recall number: D-0833-2020.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the U.S. and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0833-2020) 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 February 19, 2020. 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.