CLASS III Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Cetirizine Hydrochloride Chewable Tablets, 5 mg recalled
Caraco Pharmaceutical Laboratories is recalling Cetirizine Hydrochloride Chewable Tablets, 5 mg, distributed nationwide in the US. The recall was initiated on 9 Apr 2014 and the FDA has classified it as Class III.
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-1296-2014
- FDA event ID
- 67971
- Recalling firm
- Caraco Pharmaceutical Laboratories, Detroit, MI
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Apr 2014
- FDA classified
- 1 May 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 9 Apr 2014 | Recall initiated by company | |
| 1 May 2014 | Classified by FDA | +22 days |
| 7 May 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Which lots are affected?
JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 67971| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg recalled | Caraco Pharmaceutical Laboratories | Potency & Assay | Nationwide |
More recalls from Caraco Pharmaceutical Laboratories
All 12Other Cetirizine recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cetirizine Hydrochloride Tablets USP 5 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 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., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Cetirizine hydrochloride recalled by A-S Medication SolutionsCetirizine | A-S Medication Solutions | Other | 4 states |