Recall archive / FDA company announcement
Rising Pharma Holdings Inc.: Cetirizine Hydrochloride Tablets USP 5 mg — FDA announcement Jul 20, 2026
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Jul 20, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Cetirizine Hydrochloride Tablets USP 5 mg
- Reason
- Potential cross contamination with Ranitidine
- Classification
- Not supplied
- Recalling firm
- Unique Pharmaceutical Laboratories
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- f9e62af82fa62fd1
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | The product subject to this recall is listed below and packaged in HDPE bottles. The product can be identified by reviewing the product name, manufacturer details and lot number displayed on the bottle. Product was distributed Nationwide to several wholesalers/retailers.; NDC | Manufacturer | Distributed By | Product Description | Lot Numbers | Expiration Date; 16571-401-10 | Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) | Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container | GY825029 | 10/2028; 16571-401-10 | Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) | Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container | GY825030 | 10/2028; 16571-401-10 | Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) | Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container | GY825031 | 10/2028; 16571-401-10 | Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) | Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container | GY825032 | 10/2028 |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| NDC | Manufacturer | Distributed By | Product Description | Lot Numbers | Expiration Date |
|---|---|---|---|---|---|
| 16571-401-10 | Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) | Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container | GY825029 | 10/2028 |
| 16571-401-10 | Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) | Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container | GY825030 | 10/2028 |
| 16571-401-10 | Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) | Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container | GY825031 | 10/2028 |
| 16571-401-10 | Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) | Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container | GY825032 | 10/2028 |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
The product subject to this recall is listed below and packaged in HDPE bottles. The product can be identified by reviewing the product name, manufacturer details and lot number displayed on the bottle. Product was distributed Nationwide to several wholesalers/retailers.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Fda listing date
- Jul 20, 2026
- Company announcement date
- Jul 18, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.