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.
What this means for you
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.
Related recalls
Same brand · BUPRENORPHINE
- ModerateBuprenorphine Sublingual Tablets Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2023-06-14
- ModerateTeva Recalls Buprenorphine Transdermal Patches for Stability Failures
FDA (Drugs) · 2020-10-07
Same manufacturer · American Health Packaging
See all →- ModerateNitrofurantoin Capsules 100 mg recalled for failed dissolution specifications
FDA (Drugs) · 2022-05-25
- ModerateCyanocobalamin Injection Recalled Due to Subpotency and Assay Non-Compliance
FDA (Drugs) · 2022-05-04
- SevereOxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure
FDA (Drugs) · 2022-03-16
- ModerateMetoprolol Succinate ER Tablets Recall for Failed Dissolution
FDA (Drugs) · 2022-02-02
- ModerateGlipiZIDE Extended-Release Tablets 2.5 mg Nationwide Recall
FDA (Drugs) · 2021-10-27
Same hazard · mis labeling
See all →- CriticalFDA Recalls Gluten-Free Veggie Chips for Undeclared Wheat
FDA (Food) · 2026-09-16
- ModerateWheel Pros Recalls 549 Avix TrailTek RT Tires for Incorrect Markings
NHTSA · 2026-09-10
- HighPrince Bakery Recalls Sesame French Bread for Undeclared Allergen
FDA (Food) · 2026-09-09
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-09
- ModerateWonton Skin Recalled for Undeclared Red Dye
FDA (Food) · 2026-09-09