CLASS II Drug recall · Reported 28 Jan 2015 · FDA Enforcement Report
Lamotrigine Tablets, 200 mg per blister card x 10 blister recalled
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Lamotrigine Tablets, 200 mg per blister card x 10 blister cards per carton), distributed nationwide in the US. The recall was initiated on 26 Sep 2013 and the FDA has classified it as Class II.
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-0378-2015
- FDA event ID
- 66607
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Sep 2013
- FDA classified
- 21 Jan 2015
- Reported
- 28 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Seizure Medication
Timeline
| 26 Sep 2013 | Recall initiated by company | |
| 21 Jan 2015 | Classified by FDA | +482 days |
| 28 Jan 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Product as listed by the FDA
LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Which lots are affected?
Lot Number: 3038124; Expiration Date: 1/14; NDC: 51079-866-20;
Where was it sold?
Nationwide and Puerto Rico.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
1 other product · FDA event 66607This product is part of a recall event; the main page for the event is Ciprofloxacin Tablets, USP, 500 mg per blister card recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ciprofloxacin Tablets, USP, 500 mg per blister card recalled | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
All 22Other 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 HealthLamotrigine Extended Release | 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 |