FDA Drug recall D-1329-2022
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc
- FDA Drug
- Class III
- terminated
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class III recall of Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc by Avkare, citing labeling: Label Error on Declared Strength.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1329-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-07-20 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
Product
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
Reason
Labeling: Label Error on Declared Strength
Identifiers
| upc | 342291367104 |
|---|---|
| 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 #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022 |
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-1329-2022%22
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