Class II · Moderate risk
Imipramine Pamoate Capsules 125 mg
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Is Imipramine recalled?
Not under an active recall.
Imipramine was recalled 5 times in the past — all now closed. Most recent: Oct 8, 2021.
Most common reason: Chemical / undeclared (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Imipramine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Imipramine recalls on record
none so far in 2026; 5 on record, newest first
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class II · Moderate risk
Imipramine HCL
Labeling: Label Mixup: IMIPRAMINE HCL, Tablet, 25 mg may have potentially been mislabeled as the following drug: FENOFIBRATE, Tablet, 54 mg, NDC 00115551110, Pedigree: AD49448_7, EXP: 5/17/2014.
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