FDA Drug recall D-1289-2020
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: A…
- FDA Drug
- Class III
- terminated
- Published 2020-06-10
On 2020-06-10 the FDA classified a Class III recall of 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: A… by Avkare, citing presence of Foreign Substance consistent with granules from desiccant packs used during storage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1289-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-05-28 |
| Published | 2020-06-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
Product
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
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Identifiers
| ndc | 42291-366-01 |
|---|---|
| ndc | 42291-366-10 |
| ndc | 42291-367-01 |
| ndc | 42291-367-10 |
| ndc | 42291-368-60 |
| ndc | 42291-368-50 |
| ndc | 42291-369-60 |
| ndc | 42291-369-50 |
| code_info | Lot #: a) 25634, b) 25633; Exp. 09/30/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1289-2020%22
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