Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported June 10, 2020
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Avkare Inc. recalled Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 c… - a low-severity action.
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 c… was recalled by Avkare Inc. in June 10, 2020. Reason: Presence of Foreign Substance consistent with granules from desiccant packs used during storage. Check the official notice for the remedy. Verify recall #D-1289-2020 with the FDA Drug before acting.
The recall
Avkare Inc. issued this low-severity FDA Drug recall-Presence of Foreign Substance consistent with granules from desiccant packs used during storage.
- Low
- severity level
- Class III
- classification
- June 10, 2020
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1289-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1289-2020) was formally reported on June 10, 2020, with the manufacturer initiating the action on May 28, 2020. It is classified under Low severity (Class III), with a current status of Terminated. Avkare Inc. is listed as the recalling firm, operating out of Pulaski, TN. Federal records list the affected scope as 4124 bottles.
The documented reason for this recall is: Presence of Foreign Substance consistent with granules from desiccant packs used during storage Distribution data in the federal record shows the product reached: Nationwide in the U.S.. 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
4124 bottles
Related Recalls
6
0 from same agency
Product description
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
Reason for recall
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1289-2020 |
| Date reported | June 10, 2020 |
| Date initiated | May 28, 2020 |
| Recalling firm | Avkare Inc. |
| Firm location | Pulaski, TN |
| Affected scope | 4124 bottles |
| Distribution | Nationwide in the U.S. |
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-1289-2020) 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.
- 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 Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.. Recalled by Avkare Inc.. Units affected: 4124 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 10, 2020. Severity: Low. Recall number: D-1289-2020.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the U.S..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1289-2020) 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 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 June 10, 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.