Pecgen DMX Recalled for Incorrect Pediatric Dosage Labeling
Novis PR, Inc. is recalling Pecgen DMX cough syrup because a typo on the label provides incorrect dosage instructions for children.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, but the hazard is a labeling error (typo) rather than a contamination or structural defect. Per the rubric, minor labeling errors and voluntary precautionary recalls are typically Moderate (2), as the risk is theoretical and no injuries are reported.
Plain-English summary
Novis PR, Inc. is recalling 5,766 bottles of Pecgen DMX (Dextromethorphan HBr, Guaifenesin) cough suppressant and expectorant. The product was distributed in Puerto Rico. The recall involves specific lots with expiration dates of 02/20 and 09/20.
The recall was initiated due to a typographical error on the drug facts label that provides incorrect dosage information for children. The label incorrectly states that children 6 to under 2 years of age should take 1 teaspoonful every 4 hours. The correct instruction should state that children 6 to under 12 years of age should take 1 teaspoonful every 4 hours. Additionally, the label fails to advise consumers to consult a doctor for children under 2 years of age.
Consumers with this product should stop using it and return it to the point of purchase or contact the manufacturer for instructions.
The recalled product
- Product
- PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN)
- Brand
- PECGEN DMX
- Manufacturer
- Novis PR, Inc.
- Category
- Drug — OTC Cough Medicine
- Affected units
- 5,766
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 (5)
- Lot #s: D80202
- D80210 Exp. 02/20
- D80818
- D80819 Exp. 09/20
- D80820 Exp. 09/20
UPCs (1)
- 0352083630163
Distribution
Distributed in 1 state:
Related recalls
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02