Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Guanfacine recalled?

Yes — there is an active recall. 1 ongoing FDA recall mention Guanfacine (4 total). Check the affected lots below.

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 Guanfacine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Guanfacine recalls on record

none so far in 2026; 4 on record, newest first
Class II · Moderate risk

guanFACINE HCl

Labeling: Label Mixup: guanFACINE HCl, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: W002727, EXP: 6/6/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD39588_7, EXP: 5/13/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003873, EXP: 6/2

Terminated Labeling / mix-up Aidapak Services, LLC D-965-2014
Class II · Moderate risk

guanFACINE HC

Labeling: Label Mixup: guanFACINE HC, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: AD46265_22, EXP: 5/15/2014; FOSINOPRIL SODIUM, Tablet, 10 mg, NDC 60505251002, Pedigree: AD46414_19, EXP: 5/16/2014; chlorproMAZINE HCl, Tablet, 100 mg, NDC 00832030300, Pedigree: AD70629_4, EXP: 5/29/2014; guanFACINE HCl,

Terminated Labeling / mix-up Aidapak Services, LLC D-895-2014
Class II · Moderate risk

guanFACINE HCl Tablet

Labeling:Label Mixup; guanFACINE HCl Tablet, 2 mg may be potentially mislabeled as buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: AD21790_4, EXP: 5/1/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002997, EXP: 6/11/2014; glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: W003677, EXP: 2/28/2014; ACYCLOVIR, Capsule, 200 mg, NDC 00093894001, Pedigree: AD60

Terminated Labeling / mix-up Aidapak Services, LLC D-711-2014