FDA Drug recall D-0772-2023
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratori…
- FDA Drug
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratori… by Denison Pharmaceuticals, citing CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0772-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-03 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Denison Pharmaceuticals |
| Distribution | US |
Product
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Reason
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Identifiers
| code_info | Lot: 8314, Exp: 04/2023, 8753, 8753A, Exp: 10/2023; 8659, Exp: 08-2023 |
|---|
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-0772-2023%22
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