FDA Drug recall D-0033-2025
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in carto…
- FDA Drug
- Class III
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class III recall of Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in carto… by Denison Pharmaceuticals, citing crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0033-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-09-25 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Denison Pharmaceuticals |
| Distribution | n/a |
Product
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155
Reason
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Identifiers
| upc | 850015736155 |
|---|---|
| ndc | 69676-0079-3 |
| ndc | 69676-0077-9 |
| ndc | 69676-0094-9 |
| ndc | 8500157361 |
| code_info | Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024 |
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-0033-2025%22
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