AVKARE Lamotrigine Tablets 150mg Recall: Foreign Substance Risk
AVKARE recalls 150mg Lamotrigine tablets (60 and 500 count bottles) due to foreign granules from desiccant packs. Consumers should check NDC numbers and lot dates.
Lower-risk recall
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Contact the company
What happened, in plain English
AVKARE is recalling 150mg Lamotrigine tablets in 60-count and 500-count bottles because they may contain foreign granules from desiccant packs used during storage. This could cause harm if the tablets are taken as directed. Read more at govinfonow.com/recall/37090-avkare-lamotrigine-tablets-150mg-recall-foreign-substance-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37090-avkare-lamotrigine-tablets-150mg-recall-foreign-substance-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1289-2020
Cite this page
“AVKARE Lamotrigine Tablets 150mg Recall: Foreign Substance Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37090-avkare-lamotrigine-tablets-150mg-recall-foreign-substance-risk. Based on FDA recall #D-1289-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1289-2020%22&limit=1).
Why it’s dangerous
The tablets may contain granules from desiccant packs that were used during storage. These foreign substances could be ingested if the tablets are taken as prescribed, potentially causing harm.
Who’s affected
People who have the 60-count or 500-count bottles of 150mg Lamotrigine tablets with NDC numbers 42291-368-60 or 42291-368-50 are affected. Those taking the medication for seizures or other conditions are most at risk.
How to tell if you have this one
Check for the NDC numbers 42291-368-60 (60-count bottle) or 42291-368-50 (500-count bottle). The lot numbers are 25634 for the 60-count bottle and 25633 for the 500-count bottle, both expiring September 30, 2021.
- Brand
AVKARE- Category
Drug
What to do — step by step
Check Product Details
Look for NDC numbers 42291-368-60 or 42291-368-50 on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates a potential risk, but the product is not unsafe if stored properly without desiccant packs.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1289-2020 (May 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1289-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.