AVKARE recalls 1000-count Lamotrigine 100mg tablets (Rx only) due to labeling error on declared strength. Affected lots expire 2022-2024. No action needed as it's a labeling issue, not a safety hazard.
Labeling: Label Error on Declared Strength
AVKARE is recalling 1000-count bottles of 100mg Lamotrigine tablets (Rx only) because the label shows the wrong strength. This is a labeling error, not a safety risk, so no action is required.
The label shows an incorrect strength, which could lead to confusion about the medication dose. However, this is a labeling error, not a safety hazard that causes injury or illness.
People with prescriptions for Lamotrigine 100mg who received these specific lots from AvKARE. Those with the product are most at risk if they misread the label.
Check for Lamotrigine 100mg tablets with the lot numbers 38723 (exp. 02/2023), 37623 (exp. 10/2022), 38723 (exp. 02/2023), 41204 (exp. 05/2024), 42484 (exp. 11/2024), or 42581 (exp. 12/2024).
Verify the lot number and expiration date on the bottle to confirm if it's affected.
No, this is a labeling error, not a safety issue. The product is safe to use as intended.
No action is needed. This is a labeling error, not a safety hazard.
Affected lots: 38723 (exp. 02/2023), 37623 (exp. 10/2022), 41204 (exp. 05/2024), 42484 (exp. 11/2024), 42581 (exp. 12/2024).
We’ve drafted a message you can send AVKARE to request your refund or repair — edit it as you like.
Subject: Recall D-1329-2022 — AVKARE AVKARE Hello, I own a AVKARE that is covered by recall D-1329-2022 from AVKARE. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
