CLASS I Drug recall · Reported 7 Jun 2023 · FDA Enforcement Report
G-Supress DX (Dextromethorphan HBr, Guaifenesin recalled by Novis PR
Novis PR is recalling G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough, distributed in Puerto Rico. The recall was initiated on 20 Apr 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0868-2023
- FDA event ID
- 92324
- Recalling firm
- Novis PR, San Juan, PR
- Brand
- G-supress Dx
- Manufacturer
- KRAMER NOVIS
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 Apr 2023
- FDA classified
- 6 Jun 2023
- Reported
- 7 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Nasal Sprays
Timeline
| 20 Apr 2023 | Recall initiated by company | |
| 6 Jun 2023 | Classified by FDA | +47 days |
| 7 Jun 2023 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Puerto Rico
Questions about this recall
Why was it recalled?
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Which lots are affected?
Lot: D20911, Exp. Oct/25
Where was it sold?
Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Novis PR
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt recalledPreProtein | Novis PR | Other | PR |
| Food | CLASS II | PreProtein, Liquid Predigested Protein, Dietary Supplement recalledPreProtein | Novis PR | Other | PR |
| Food | CLASS II | GPre Protein, Liquid predigested Protein recalled by Novis PRGPre | Novis PR | Foreign Material | PR |
| Food | CLASS III | G-preprotein, Liquid Predigested Protein recalled by Novis PR | Novis PR | Other | PR |
| Drug | CLASS I | Pecgen DMX Cough Suppressant Expectorant recalled by Novis PRPecgen Dmx | Novis PR | Other | PR |
Other Dextromethorphan Hydrobromide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nuedexta (dextromethorphan HBr recalled by Cardinal HealthNuedexta | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Sorbugen NR (Dextromethorphan HBr, 15 mg recalled by Pharma-NaturalSorbugen | Pharma-Natural | Potency & Assay | Nationwide |