Class II · Moderate risk
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Is Clomipramine recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Clomipramine (9 total). Check the affected lots below.
Most common reason: Nitrosamine impurity (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Clomipramine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Clomipramine recalls on record
none so far in 2026; 9 on record, newest first
Class II · Moderate risk
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II · Moderate risk
clomiPRAMINE Hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Class II · Moderate risk
clomiPRAMINE Hydrochloride Capsules USP 25 mg
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Class II · Moderate risk
clomiPRAMINE hydrochloride Capsules USP
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Class III · Low risk
ClomiPRAMINE Hydrochloride Capsules
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Class II · Moderate risk
clomiPRAMINE Hydrochloride Capsules USP
Failed Tablet/Capsule Specification
Class II · Moderate risk
Clomipramine HCI active pharmaceutical ingredient packaged in…
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
clomiPRAMINE HCl Capsule
Labeling: Label Mixup; clomiPRAMINE HCl Capsule, 50 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46265_25, EXP: 5/15/2014; CHLORTHALIDONE, Tablet, 50 mg, NDC 00378021301, Pedigree: W002988, EXP: 6/11/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W003674, EXP: 6/25/2014; ISOSORBIDE MONONITRATE, Tablet, 10 mg, NDC 6217501060
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