CLASS II Drug recall · Reported 13 Nov 2013 · FDA Enforcement Report

Lamotrigine Tablets, USP, 200 mg recalled by Mylan Pharmaceuticals

Mylan Pharmaceuticals is recalling Lamotrigine Tablets, USP, 200 mg, distributed nationwide in the US. The recall was initiated on 13 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) 2003194, 2003195; b) 2003193

Quantity recalled28,140 bottles

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-66403-003
FDA event ID: 66403
Recalling firm: Mylan Pharmaceuticals, Morgantown, WV
Classification: Class II
Status: Terminated
Recall initiated: 13 Sep 2013
FDA classified: 4 Nov 2013
Reported: 13 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Seizure Medication

Timeline

13 Sep 2013	Recall initiated by company
4 Nov 2013	Classified by FDA	+52 days
13 Nov 2013	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

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, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Where it was distributed

Nationwide and Puerto Rico

Nationwide 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 #: a) 2003194, 2003195; b) 2003193

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

11 other products · FDA event 66403

This product is part of a recall event; the main page for the event is Ciprofloxacin Tablets, USP, 500 mg recalled by Mylan Pharmaceuticals.

Reported	Class	Recall	Company	Reason	Where
13 Nov 2013	CLASS II	Ciprofloxacin Tablets, USP, 500 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
13 Nov 2013	CLASS II	Amlodipine Besylate Tablets, USP 10 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
13 Nov 2013	CLASS II	Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg recalled	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
13 Nov 2013	CLASS II	Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg recalled	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
13 Nov 2013	CLASS II	Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg recalled	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
13 Nov 2013	CLASS II	Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg recalled	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
13 Nov 2013	CLASS II	Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg recalled	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
13 Nov 2013	CLASS II	Amlodipine Besylate Tablets, USP, 5 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
13 Nov 2013	CLASS II	Ciprofloxacin Tablets, USP, 250 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
13 Nov 2013	CLASS II	Amlodipine Besylate Tablets, USP, 2.5 mg recalled	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
13 Nov 2013	CLASS II	Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg recalled	Mylan Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Mylan Pharmaceuticals

All 84

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel	Mylan Pharmaceuticals	Potency & Assay	Nationwide
9 Sep 2026Drug	CLASS II	Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Potency & Assay	Nationwide
26 Aug 2026Drug	CLASS II	Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium	Mylan Pharmaceuticals	Potency & Assay	Nationwide
5 Aug 2026Drug	CLASS II	Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil	Mylan Pharmaceuticals	Other	Nationwide
11 Mar 2026Drug	CLASS II	Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem	Mylan Pharmaceuticals	Potency & Assay	Nationwide

Other Lamotrigine recalls

All 11

Reported	Class	Recall	Company	Reason	Where
17 Aug 2022Drug	CLASS III	Lamotrigine Tablets, USP 100 mg recalled by AvkareLamotrigine	Avkare	Other	Nationwide
2 Jun 2021Drug	CLASS II	Lamotrigine Extended-Release Tablets 250 mg recalled by Cardinal Health	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
10 Jun 2020Drug	CLASS III	Lamotrigine Tablets, USP, 150 mg recalled by AvkareLamotrigine	Avkare	Other	Nationwide
3 Jun 2020Drug	CLASS III	Lamotrigine Tablets, USP, 150 mg bulk container recalled	Jubilant Cadista Pharmaceuticals	Packaging Defects	TN
19 Feb 2020Drug	CLASS I	Lamotrigine Tablets, USP, 100 mg recalled by Taro Pharmaceuticals U.S.ALamotrigine	Taro Pharmaceuticals U	Other	Nationwide