Recall archive / FDA drug enforcement
G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nas... — FDA record D-0868-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 20, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor Sugar & Alcohol Free, packaged in a bottle Net Content: 30 mL (1 oz.) further packaged in a carton, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-655-01
- Reason
- Product mix-up: incorrect product was found inside the G-Supress DX product carton.
- Classification
- Class I
- Recalling firm
- Novis PR, LLC dba Kramer Novis
- Quantity
- 9077 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0868-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot: D20911, Exp. Oct/25 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Puerto Rico
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 7, 2023
- Recall initiation date
- Apr 20, 2023
- Center classification date
- Jun 6, 2023
- Termination date
- Sep 13, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.