Why it was recalled
Presence of a foreign substance.
Product description
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
Lot numbers, UPCs & expiration codes
Lot # 47089, Exp 12/31/25; 47604, Exp 03/31/26
Where it was sold
USA Nationwide
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-0644-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 25, 2025
- FDA report date
- Sep 17, 2025
- Quantity
- 2003 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AvKARE
Original FDA data
Every field from FDA enforcement report D-0644-2025, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 97548
- Address
- 615 N 1st St
- Code information
- Lot # 47089, Exp 12/31/25; 47604, Exp 03/31/26
- Postal code
- 38478-2403
- Report date
- Sep 17, 2025
- Product type
- Drugs
- Recall number
- D-0644-2025
- Classification
- Class II
- Recalling firm
- AvKARE
- Product quantity
- 2003 cartons
- Reason for recall
- Presence of a foreign substance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Aug 25, 2025
- Initial firm notification
- Center classification date
- Sep 11, 2025