Mucinex DM — Class III drug recall D-0964-2015
Terminated recall by Reckitt Benckiser LLC, reported 2015-04-29, distributed nationwide. Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex po
| Recall number | D-0964-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reckitt Benckiser LLC, Parsippany, NJ, United States |
| Recall initiated | 2014-11-10 |
| Classified | 2015-04-21 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2018-03-30 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| NDC | 63824-0056, 63824-0056-01, 63824-0056-11, 63824-0056-32, 63824-0056-34, 63824-0056-36, 63824-0056-50, 63824-0056-69, 63824-0056-72, 63824-0056-73, 63824-0056-74, 63824-0056-80, 63824-0056-89 |
| Lot numbers | BD375, BD566, BD661 |
| Expiration dates | 2016-06, 2016-08 |
Product
Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OTC, Distributed by Reckitt Benckiser, Parsippany, NJ 07054-0224 Made in England
Reason for recall
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
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-0964-2015. 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.