Class II · Moderate risk
S-Amitriptyline 10mg/Ml Mdv Inj Soln
Lack of Assurance of Sterility
Is Amitriptyline recalled?
Not under an active recall.
Amitriptyline was recalled 6 times in the past — all now closed. Most recent: Aug 12, 2019.
Most common reason: Cross-contamination (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amitriptyline. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Amitriptyline recalls on record
none so far in 2026; 6 on record, newest first
Class II · Moderate risk
Amitriptyline HCl USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class III · Low risk
Amitriptyline HCl Tablets
Cross Contamination With Other Product: Imipramine
Class II · Moderate risk
Amitriptyline HCL Tablets
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
All ketamine and amitriptyline Products
Lack of Processing Controls
Class II · Moderate risk
Amitriptyline HCl 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.
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