Safe tussin PM — Class II drug recall D-0775-2023
Ongoing recall by Denison Pharmaceuticals, LLC, reported 2023-06-07, distributed nationwide. CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
| Recall number | D-0775-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Denison Pharmaceuticals, LLC, Lincoln, RI, United States |
| Recall initiated | 2023-05-03 |
| Classified | 2023-05-31 |
| Reported by FDA | 2023-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 13,968 bottles |
| Reason classes | cgmp |
| Lot numbers | 8639 |
| Expiration dates | 2023-08 |
Product
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Reason for recall
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
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-0775-2023. 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.