Buprenorphine Sublingual Tablets Recalled for Labeling Mix-up
American Health Packaging is recalling 10,953 cartons of Buprenorphine Sublingual Tablets due to a label mix-up. The affected lot is distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific hazard is a labeling mix-up, which falls under minor labeling errors.
Plain-English summary
American Health Packaging is voluntarily recalling 10,953 cartons of Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10). The recall is being conducted due to a labeling issue described as a "Label Mix-up." The affected product is identified by Lot # 1030023 with an expiration date of 06/30/2027. The product is distributed by American Health Packaging in Columbus, Ohio, and is available under NDC 60687-481-21.
The recall covers distribution across the United States. The agency has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled description, it should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- BUPRENORPHINE (BUPRENORPHINE)
- Brand
- BUPRENORPHINE
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 10,953
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 # 1030023
- Exp Date: 06/30/2027.
Distribution
Distributed nationwide across the United States.
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