Cherry Cepacol Sore Throat Lozenges — Class III drug recall D-310-2013
Terminated recall by Reckitt Benckiser Inc, reported 2013-05-08, distributed nationwide. Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocain
| Recall number | D-310-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reckitt Benckiser Inc, Parsippany, NJ, United States |
| Recall initiated | 2013-03-18 |
| Classified | 2013-05-01 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2014-08-14 |
| Distributed | Nationwide (US) |
| Reason classes | potency, specification failure |
| NDC | 63824-0711-16, 63824-0711-98 |
Product
Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054
Reason for recall
Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.
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-310-2013. 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.