Why it was recalled
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Product description
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, 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 16571-401-10.
Lot numbers, UPCs & expiration codes
Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Where it was sold
Nationwide in the USA
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-0732-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jun 24, 2026
- FDA report date
- Jul 29, 2026
- Quantity
- 34,020 100-count bottles.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd
Original FDA data
Every field from FDA enforcement report D-0732-2026, exactly as published.
Show all FDA fields
- City
- Mumbai
- Status
- Ongoing
- Country
- India
- Event ID
- 99321
- Address
- Neelam Centre A Wing A B Wing
- Address (line 2)
- 4th Floor; Hind Cycle Road
- Code information
- Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
- Report date
- Jul 29, 2026
- Product type
- Drugs
- Recall number
- D-0732-2026
- Classification
- Class I
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd
- Product quantity
- 34,020 100-count bottles.
- Reason for recall
- Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, 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 16571-401-10.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 24, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 3, 2026