Class II · Moderate risk
Benztropine Mesylate Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Is Benztropine recalled?
Not under an active recall.
Benztropine was recalled 4 times in the past — all now closed. Most recent: Mar 15, 2021.
Most common reason: Particulate / foreign matter (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Benztropine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Benztropine recalls on record
none so far in 2026; 4 on record, newest first
Class II · Moderate risk
Benztropine Mesylate 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
Benztropine Mesylate Injection
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Class II · Moderate risk
Benztropine Mesylate Injection
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.