Class II · Moderate risk
Spiriva Handihaler
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Is Tiotropium recalled?
Not under an active recall.
Tiotropium was recalled 5 times in the past — all now closed. Most recent: Jan 26, 2022.
Most common reason: Temperature excursion (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tiotropium. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Tiotropium recalls on record
none so far in 2026; 5 on record, newest first
Class II · Moderate risk
Spiriva HandiHaler
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
SPIRIVA HandiHaler
Failed Stability Specifications
Class III · Low risk
Spiriva HandiHaler
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
Class III · Low risk
SPIRIVA HandiHaler
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
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