Class II · Moderate risk
Sumatriptan Succinate Tablets
cGMP deviations: Temperature abuse
Is Sumatriptan recalled?
Not under an active recall.
Sumatriptan was recalled 9 times in the past — all now closed. Most recent: Apr 13, 2022.
Most common reason: Impurity / degradation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sumatriptan. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Sumatriptan recalls on record
none so far in 2026; 9 on record, newest first
Class II · Moderate risk
Sumatriptan Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Sumatriptan Succinate Tablets
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk
Sumatriptan Succinate Tablets
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk
Sumatriptan 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 II · Moderate risk
Sumatriptan Succinate 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 II · Moderate risk
Sumatriptan Succinate active pharmaceutical ingredient packaged…
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
Sumatriptan Succinate Injection
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Class II · Moderate risk
Imitrex STATdose System
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
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