CLASS III Drug recall · Reported 10 Jun 2020 · FDA Enforcement Report
Lamotrigine Tablets, USP, 150 mg recalled by AVKARE
Avkare is recalling Lamotrigine Tablets, USP, 150 mg, distributed nationwide in the US. The recall was initiated on 28 May 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1289-2020
- FDA event ID
- 85783
- Recalling firm
- Avkare, Pulaski, TN
- Brand
- Lamotrigine
- Manufacturer
- AvKARE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 May 2020
- FDA classified
- 4 Jun 2020
- Reported
- 10 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Seizure Medication
Timeline
| 28 May 2020 | Recall initiated by company | |
| 4 Jun 2020 | Classified by FDA | +7 days |
| 10 Jun 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Which lots are affected?
Lot #: a) 25634, b) 25633; Exp. 09/30/2021
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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Other Lamotrigine recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lamotrigine Tablets, USP 100 mg recalled by AVKARELamotrigine | Avkare | Other | Nationwide |
| Drug | CLASS II | Lamotrigine Extended-Release Tablets 250 mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Lamotrigine Tablets, USP, 150 mg bulk container recalled | Jubilant Cadista Pharmaceuticals | Packaging Defects | TN |
| Drug | CLASS I | Lamotrigine Tablets, USP, 100 mg recalled by Taro Pharmaceuticals U.S.ALamotrigine | Taro Pharmaceuticals U | Other | Nationwide |
| Drug | CLASS II | Lamotrigine Extended-Release Tablets, USP, 200 mg recalledLamotrigine | Torrent Pharma | Potency & Assay | Nationwide |