Class III · Lower riskActive recall
Cetirizine Hydrochloride
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot # PY925014, PY925013, Exp. 1/31/2028
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Tablet/Capsules Imprinted with Wrong ID
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byUnique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816 foreign manufacturer
| Brand name | CETIRIZINE HYDROCHLORIDE |
| Generic name | CETIRIZINE HYDROCHLORIDE |
| Active ingredient(s) | CETIRIZINE HYDROCHLORIDE |
| Distributed by / for | Rising Pharma Holdings, Inc., East Brunswick, NJ 08816 |
| NDC | 16571-402-50 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | JB Chemicals and Pharmaceuticals Ltd |
| Distribution | U.S. Nationwide |
| Quantity | 13,440 bottles |
| Recall initiated | 2025-09-12 |
| Report date | 2025-10-29 |
| Recall completed | — |
| Recall number | D-0033-2026 |
| Classification | Class III |
| FDA status | Ongoing |
| Origin on file | Mumbai India |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.