CLASS III Drug recall · Reported 3 Jun 2020 · FDA Enforcement Report
Lamotrigine Tablets, USP, 150 mg bulk container recalled
Jubilant Cadista Pharmaceuticals is recalling Lamotrigine Tablets, USP, 150 mg bulk container, distributed in Tennessee. The recall was initiated on 26 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-1281-2020
- FDA event ID
- 85752
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Salisbury, MD
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 May 2020
- FDA classified
- 29 May 2020
- Reported
- 3 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Seizure Medication
Timeline
| 26 May 2020 | Recall initiated by company | |
| 29 May 2020 | Classified by FDA | +3 days |
| 3 Jun 2020 | Published in enforcement report | +5 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 visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97.
Where it was distributed
TN
Questions about this recall
Why was it recalled?
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Which lots are affected?
Lot #s 19P0437 & 19P0438, Exp. 09/30/2021.
Where was it sold?
TN
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 Jubilant Cadista Pharmaceuticals
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Prochlorperazine Maleate Tablets, USP 5mg recalled by Jubilant CadistaProchlorperazine Maleate | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Meclizine Hydrochloride Tablets USP, 12.5 mg recalledMeclizine Hydrochloride | Jubilant Cadista Pharmaceuticals | Labeling Errors | 5 states |
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 recalled by AVKARELamotrigine | Avkare | Other | Nationwide |
| 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 |