CLASS III Drug recall · Reported 5 Oct 2016 · FDA Enforcement Report
Lamotrigine Tablets recalled by Unichem Pharmaceuticals Usa
Unichem Pharmaceuticals Usa is recalling Lamotrigine Tablets, USP per, distributed nationwide in the US. The recall was initiated on 19 Aug 2016 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-1519-2016
- FDA event ID
- 75205
- Recalling firm
- Unichem Pharmaceuticals Usa, Hasbrouck Heights, NJ
- Brand
- Lamotrigine
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Aug 2016
- FDA classified
- 23 Sep 2016
- Reported
- 5 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Seizure Medication
Timeline
| 19 Aug 2016 | Recall initiated by company | |
| 23 Sep 2016 | Classified by FDA | +35 days |
| 5 Oct 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Product as listed by the FDA
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Which lots are affected?
Lot #: GLEH 16003, Exp 03/31/18
Where was it sold?
Nationwide
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 Unichem Pharmaceuticals Usa
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | busPIRone Hydrochloride Tablets, USP, 5 mg recalledBuspirone Hydrochloride | Unichem Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Doxazosin Tablets, USP, 4 mg recalled by Unichem Pharmaceuticals USADoxazosin Mesylate | Unichem Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Bisoprolol Fumarate and Hydrochlorothiazide tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Unichem Pharmaceuticals USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS I | Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg recalledCyclobenzaprine Hydrochloride | Unichem Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS III | Clonidine Hydrochloride Tablets, USP, 0.3 mg recalledClonidine Hydrochloride | Unichem Pharmaceuticals USA | Packaging Defects | Nationwide |
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 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 |