Boehringer Ingelheim Recalls SPIRIVA HandiHaler Due to Failed Stability Specifications
Boehringer Ingelheim is recalling SPIRIVA HandiHaler (tiotropium bromide) capsules because they failed stability specifications. The recall affects 45,008 units distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level where the product may cause temporary or medically reversible adverse health consequences. No specific injuries or illnesses are reported in the source text.
Plain-English summary
Boehringer Ingelheim Pharmaceuticals, Inc. is recalling SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule. The recall is being conducted because the product failed stability specifications. The affected product is identified by Lot # 606478 with an expiration date of 03/18.
The recall involves 45,008 units, with each unit containing 90 capsules. The product was distributed nationwide. SPIRIVA is a prescription medication used for respiratory conditions.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SPIRIVA (TIOTROPIUM BROMIDE)
- Brand
- SPIRIVA
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Category
- Drug — Inhalation Powder
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 606478
- Exp. 03/18
Distribution
Distributed nationwide across the United States.
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