Why it was recalled
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Product description
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018
Lot numbers, UPCs & expiration codes
Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
Where it was sold
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0034-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Sep 25, 2024
- FDA report date
- Nov 13, 2024
- Quantity
- 105,048 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Denison Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0034-2025, exactly as published.
Show all FDA fields
- City
- Lincoln
- State
- RI
- Status
- Ongoing
- Country
- United States
- Event ID
- 95430
- Address
- 1 Powder Hill Rd
- Code information
- Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
- Postal code
- 02865-4407
- Report date
- Nov 13, 2024
- Product type
- Drugs
- Recall number
- D-0034-2025
- Classification
- Class III
- Recalling firm
- Denison Pharmaceuticals, LLC
- Product quantity
- 105,048 bottles
- Reason for recall
- Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018
- Distribution pattern
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
- Recall initiation date
- Sep 25, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 1, 2024