Pediatric Cough Suppressant G-SUPRESS DX Recalled Due to Product Mix-Up
G-SUPRESS DX pediatric drops are being recalled due to a product mix-up: an incorrect product was found inside some cartons in Puerto Rico. The recall affects 9,077 bottles (Lot D20911, expires Oct/25).
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall. Per rubric, Class I recalls never score below 4. Confirmed product mix-up hazard with no reported illnesses or deaths, making this Severe (4) rather than Critical (5).
Plain-English summary
G-SUPRESS DX is a pediatric cough suppressant, expectorant, and nasal decongestant available as oral drops in cherry flavor. The product is manufactured by Kramer Novis in Puerto Rico and contains dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride.
The manufacturer, Novis PR LLC dba Kramer Novis, has recalled the product after discovering that an incorrect product was found inside some G-SUPRESS DX cartons. The recall involves 9,077 bottles with Lot D20911, which expire in October 2025. These bottles were distributed in Puerto Rico.
Consumers who have the affected lot number should contact the manufacturer or their healthcare provider for guidance.
The recalled product
- Product
- G-SUPRESS DX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE)
- Brand
- G-SUPRESS DX
- Manufacturer
- Novis PR, LLC dba Kramer Novis
- Hazard
- Affected units
- 9,077
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: D20911
- Exp. Oct/25
UPCs (1)
- 0352083655012
Distribution
Distributed in 1 state:
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