Safe Tussin DM Cough + Chest Congestion — Class II drug recall D-0942-2023
Terminated recall by Kramer Laboratories, Inc., reported 2023-08-02, distributed nationwide. CGMP Deviations: use of non-food grade lubricant in mixing vessel.
| Recall number | D-0942-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kramer Laboratories, Inc., Bridgewater, NJ, United States |
| Recall initiated | 2023-06-23 |
| Classified | 2023-07-24 |
| Reported by FDA | 2023-08-02 |
| Terminated | 2024-03-12 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| Lot numbers | 8659, 8753, 8753A |
| Expiration dates | 2023-08, 2023-10 |
Product
Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 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-0942-2023. 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.