Class III · Low risk
Lamotrigine Tablets
Labeling: Label Error on Declared Strength
Is Lamotrigine recalled?
Not under an active recall.
Lamotrigine was recalled 13 times in the past — all now closed. Most recent: Jul 20, 2022.
Most common reason: Labeling / mix-up (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lamotrigine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lamotrigine recalls on record
none so far in 2026; 13 on record, newest first
Class II · Moderate risk
Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Lamotrigine Tablets
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Class III · Low risk
Lamotrigine Tablets
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Class I · High risk
Lamotrigine Tablets
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Class II · Moderate risk
Lamotrigine Extended-Release Tablets
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Class III · Low risk
Lamotrigine Tablets
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Class I · High risk
Lamotrigine Orally Disintegrating Tablets
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Class II · Moderate risk
Lamotrigine Extended-Release Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lamotrigine active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Lamotrigine Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Class II · Moderate risk
Lamotrigine Tablets
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk
lamoTRIgine
Labeling: Label Mixup; lamotrigine, Tablet, 50 mg (1/2 of 100 mg) may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 00603497521, Pedigree: AD73525_64, EXP: 5/30/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: AD46257_50, EXP: 5/15/2014.
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