FDA Drug recall D-0257-2024
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Col…
- FDA Drug
- Class III
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class III recall of Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Col… by Amerisource Health Services, citing superpotent drug: Assay results were slightly above specification at the time zero point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0257-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-12-26 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
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
Superpotent drug: Assay results were slightly above specification at the time zero point.
Identifiers
| ndc | 68084-214-11 |
|---|---|
| ndc | 68084-214-01 |
| code_info | Lot # 1014208, Exp Mar/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0257-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.