Why it was recalled
Tablet/Capsules Imprinted with Wrong ID
Product description
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50
Lot numbers, UPCs & expiration codes
Lot # PY925014, PY925013, Exp. 1/31/2028
Where it was sold
U.S. 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-0033-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Sep 12, 2025
- FDA report date
- Oct 29, 2025
- Quantity
- 13,440 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd
Original FDA data
Every field from FDA enforcement report D-0033-2026, exactly as published.
Show all FDA fields
- City
- Mumbai
- Status
- Ongoing
- Country
- India
- Event ID
- 97573
- Address
- Neelam Centre A Wing A B Wing
- Address (line 2)
- 4th Floor; Hind Cycle Road
- Code information
- Lot # PY925014, PY925013, Exp. 1/31/2028
- Report date
- Oct 29, 2025
- Product type
- Drugs
- Recall number
- D-0033-2026
- Classification
- Class III
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd
- Product quantity
- 13,440 bottles
- Reason for recall
- Tablet/Capsules Imprinted with Wrong ID
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Sep 12, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 17, 2025