CLASS III Drug recall · Reported 17 Aug 2022 · FDA Enforcement Report
Lamotrigine Tablets, USP 100 mg recalled by AVKARE
Avkare is recalling Lamotrigine Tablets, USP 100 mg, distributed nationwide in the US. The recall was initiated on 20 Jul 2022 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-1329-2022
- FDA event ID
- 90637
- Recalling firm
- Avkare, Pulaski, TN
- Brand
- Lamotrigine
- Manufacturer
- AvKARE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Jul 2022
- FDA classified
- 8 Aug 2022
- Reported
- 17 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Seizure Medication
Timeline
| 20 Jul 2022 | Recall initiated by company | |
| 8 Aug 2022 | Classified by FDA | +19 days |
| 17 Aug 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Error on Declared Strength
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength
Which lots are affected?
Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022
Where was it sold?
Nationwide within the United States
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.
More recalls from Avkare
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
Other Lamotrigine recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 recalled by AVKARELamotrigine | Avkare | Other | Nationwide |
| 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 |