Cardinal Health Recalls Belbuca Due to Temperature Excursions
Cardinal Health is recalling 47 cartons of Belbuca (buprenorphine hydrochloride) buccal film due to intermittent exposure to temperature excursions during storage.
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, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health Inc. is recalling 47 cartons of Belbuca (buprenorphine hydrochloride) buccal film, 600 mcg, 60 pouches. The product is manufactured for BioDelivery Sciences International, Inc. The recall is due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by lot code BL6002004. The recall covers 47 cartons distributed to Florida, Georgia, and South Carolina.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on obtaining a replacement.
The recalled product
- Product
- BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
- Brand
- BELBUCA
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 47
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)
- BL6002004
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. 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 198 products in this recall →Related recalls
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