FDA Drug recall D-0964-2015
Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OT…
- FDA Drug
- Class III
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class III recall of Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (NDC 63824-056-72), OT… by Reckitt Benckiser, citing defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0964-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-11-10 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Reckitt Benckiser |
| Distribution | US |
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
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
Identifiers
| ndc | 63824-056-89 |
|---|---|
| ndc | 63824-056-36 |
| ndc | 63824-056-32 |
| ndc | 63824-056-34 |
| ndc | 63824-056-69 |
| ndc | 63824-056-73 |
| ndc | 63824-056-74 |
| ndc | 63824-056-72 |
| ndc | 63824-056-11 |
| ndc | 63824-056-01 |
| ndc | 63824-056-50 |
| ndc | 63824-056-80 |
| code_info | Lot BD375 exp 06/2016; BD566, BD661 exp. 08/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0964-2015%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.