Benzonatate Capsules — Class III drug recall D-0257-2024
Ongoing recall by Amerisource Health Services LLC, reported 2024-01-31, distributed nationwide. Superpotent drug: Assay results were slightly above specification at the time zero point.
| Recall number | D-0257-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2023-12-26 |
| Classified | 2024-01-19 |
| Reported by FDA | 2024-01-31 |
| Distributed | Nationwide (US) |
| Quantity | 6,344 cartons |
| Reason classes | potency |
| NDC | 68084-0214, 68084-0214-01, 68084-0214-11 |
| Lot numbers | 1014208, MAR/31/2025 |
Product
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11
Reason for recall
Superpotent drug: Assay results were slightly above specification at the time zero point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0257-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.