Class II · Moderate risk
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Is Glyburide recalled?
Not under an active recall.
Glyburide was recalled 4 times in the past — all now closed. Most recent: Mar 24, 2014.
Most common reason: Labeling / mix-up (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Glyburide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Glyburide recalls on record
none so far in 2026; 4 on record, newest first
Class II · Moderate risk
glyBURIDE
Labeling: Label Mixup: glyBURIDE, Tablet, 2.5 mg may have potentially been mislabeled as one of the following drugs: sulfaSALAzine, Tablet, 500 mg, NDC 59762500001, Pedigree: AD46265_13, EXP: 5/15/2014; ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: W003687, EXP: 6/26/2014; RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: AD21790_22, EXP: 5/1/2014; carBAMazepine ER, Tablet, 100 m
Class II · Moderate risk
glyBURIDE
Labeling: Label Mixup: glyBURIDE, Tablet, 1.25 mg may have potentially been mislabeled as one of the following drugs: CYPROHEPTADINE HCL, Tablet, 4 mg, NDC 60258085001, Pedigree: W003676, EXP: 6/25/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: AD21790_1, EXP: 5/1/2014.
Class II · Moderate risk
glyBURIDE MICRONIZED
Labeling: Label Mixup: glyBURIDE MICRONIZED, Tablet, 3 mg may have potentially been mislabeled as the following drug: DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: W003154, EXP: 6/13/2014.
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