CLASS I ONGOING Drug recall · Reported 29 Jul 2026 · FDA Enforcement Report
Cetirizine Hydrochloride Tablets USP 5 mg recalled by JB Chemicals and
JB Chemicals and Pharmaceuticals is recalling Cetirizine Hydrochloride Tablets USP 5 mg, distributed nationwide in the US. The recall was initiated on 24 Jun 2026 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0732-2026
- FDA event ID
- 99321
- Recalling firm
- JB Chemicals and Pharmaceuticals, Mumbai, N/A
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 24 Jun 2026
- FDA classified
- 3 Aug 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Allergy Medication
Timeline
| 24 Jun 2026 | Recall initiated by company | |
| 29 Jul 2026 | Published in enforcement report | +35 days |
| 3 Aug 2026 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Cetirizine Hydrochloride Tablets USP 5 mg recalled?
Yes. JB Chemicals and Pharmaceuticals recalled Cetirizine Hydrochloride Tablets USP 5 mg on 24 Jun 2026. The recall is Class I and its status is Ongoing. Recall number D-0732-2026.
Why was it 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.
Which lots are affected?
Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from JB Chemicals and Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Enalapril Maleate Tablets, USP, 20 mg recalled by JB Chemicals andEnalapril Maleate | JB Chemicals and Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
Other Cetirizine recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Cetirizine Hydrochloride Tablets, USP, 10mg packs recalledCetirizine Hcl | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Cetirizine hydrochloride recalled by A-S Medication SolutionsCetirizine | A-S Medication Solutions | Other | 4 states |
| Drug | CLASS II | Cetirizine Hydrochloride Tablets, 10 mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |