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

FDA recall notice · announced January 31, 2024 · Amerisource Health Services

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot # 1014208, Exp Mar/31/2025
Quantity: 6,344 cartons
Status: Ongoing
Products in this recall event:
- 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 N (D-0257-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.