The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0378-2015·Announced 2015-01-28

Mylan Lamotrigine Tablets Recalled for CGMP Deviations

Mylan Institutional is recalling 3,993 cartons of Lamotrigine 200 mg tablets because they were not manufactured according to Good Manufacturing Practices.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible health consequences. The source text does not report specific illnesses or injuries, aligning with a Moderate severity rating for CGMP deviations without confirmed harm.

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling 3,993 cartons of Lamotrigine Tablets, 200 mg. The affected product is identified by NDC 51079-866-20, Lot Number 3038124, and an expiration date of 1/14. The product was distributed nationwide and in Puerto Rico.

The recall was initiated because the pharmaceuticals were produced and distributed with active ingredients that were not manufactured according to Good Manufacturing Practices (CGMP). This classification indicates a deviation from required manufacturing standards.

Consumers and healthcare providers should check their inventory for the specific lot number and NDC listed above. If the product is found, it should be returned to the pharmacy or supplier for disposal or replacement.

The recalled product

Product
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
Manufacturer
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Category
Drug — Anticonvulsant
Hazard
Affected units
3,993

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot Number: 3038124
  • Expiration Date: 1/14
  • NDC: 51079-866-20

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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