Prescription drug SPIRIVA recalled for temperature storage deviation
SPIRIVA (tiotropium bromide) inhalation powder batch 104440 is being recalled nationwide due to exposure to temperatures outside the product's labeled storage conditions during manufacturing.
What this means for you
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: FDA Class II recall with no reported illnesses or injuries and no documented evidence of actual product harm. The hazard is theoretical—potential loss of drug stability from temperature exposure—making this a precautionary manufacturing deviation recall.
Plain-English summary
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder), 18 mcg capsules, is being recalled due to manufacturing process deviations. The affected product is batch 104440, comprising 5 units distributed nationwide.
The recall was initiated because product in this batch was exposed to temperatures outside the storage conditions specified on the product label. This occurred during manufacturing and distribution, and may affect the product's stability and quality.
Consumers who have product from batch 104440 should contact their healthcare provider or pharmacist. Do not discontinue use of this medication without consulting your healthcare provider, as SPIRIVA is used to maintain control of chronic obstructive pulmonary disease.
The recalled product
- Product
- SPIRIVA (TIOTROPIUM BROMIDE)
- Brand
- SPIRIVA
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug
- Affected units
- 5
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 (1)
- Batch 104440
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by CARDINAL HEALTHCARE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
Same brand · SPIRIVA
- ModerateCardinal Health Recalls Spiriva Inhalers Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateBoehringer Ingelheim Recalls SPIRIVA HandiHaler Due to Failed Stability Specifications
FDA (Drugs) · 2018-02-07
- LowBoehringer Ingelheim Recalls Spiriva HandiHaler Due to Defective Delivery System
FDA (Drugs) · 2014-04-16
- ModerateBoehringer Ingelheim Recalls SPIRIVA HandiHaler Due to Foreign Particles
FDA (Drugs) · 2013-09-25
Same manufacturer · CARDINAL HEALTHCARE
See all →- HighAlbuterol Sulfate Inhaler Recalled Due to Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- ModerateMeloxicam 15 mg tablets recalled for exposure to improper storage temperatures
FDA (Drugs) · 2024-01-03
- HighPredniSONE Tablets Recalled for Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- HighLow-dose aspirin recall due to improper storage temperature conditions
FDA (Drugs) · 2024-01-03
- HighBumetanide Tablets Recalled for Exposure to Improper Storage Temperatures
FDA (Drugs) · 2024-01-03
Same hazard · improper storage temperature
See all →- HighPotato Salad Recalled for Improper Temperature Storage During Distribution
FDA (Food) · 2024-02-14
- ModerateGuardian Antacid Products Recalled Due to Improper Storage Conditions
FDA (Drugs) · 2022-08-31
- HighTopical ointment recall due to improper storage temperature conditions
FDA (Drugs) · 2022-08-31
- ModeratePain Reliever Caplets Recalled for Improper Storage Temperature
FDA (Drugs) · 2022-08-31
- HighMultiple Cold and Flu Medications Recalled Due to Improper Storage Conditions
FDA (Drugs) · 2022-08-31