Class II · Moderate risk
Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply
Lack of Processing Controls.
Is Glatiramer recalled?
Not under an active recall.
Glatiramer was recalled 4 times in the past — all now closed. Most recent: Apr 3, 2018.
Most common reason: Particulate / foreign matter (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Glatiramer. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Glatiramer recalls on record
none so far in 2026; 4 on record, newest first
Class II · Moderate risk
Copaxone (glatiramer acetate injection)
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Class II · Moderate risk
Copaxone (glatiramer acetate injection)
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Class II · Moderate risk
Copaxone (glatiramer acetate injection)
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
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