Sun Pharma Recalls Children's Cetirizine Tablets for Hardness Issue
Sun Pharmaceutical recalls 13,200 bottles of Children's Cetirizine Hydrochloride Chewable Tablets due to failed tablet hardness specifications.
Lower-risk recall
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Contact the company
What happened, in plain English
Sun Pharmaceutical Industries is recalling one lot of Children's Cetirizine Hydrochloride Chewable Tablets because the tablets are harder than specified. This defect could affect how the medication dissolves or is taken. The recall involves 13,200 bottles distributed nationwide in the USA and Puerto Rico. Read more at govinfonow.com/recall/41723-sun-pharma-recalls-children-s-cetirizine-tablets-for-hardness-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/41723-sun-pharma-recalls-children-s-cetirizine-tablets-for-hardness-issue · Updated October 11, 2026 · FDA enforcement record: FDA #D-0857-2017
Cite this page
“Sun Pharma Recalls Children's Cetirizine Tablets for Hardness Issue.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41723-sun-pharma-recalls-children-s-cetirizine-tablets-for-hardness-issue. Based on FDA recall #D-0857-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0857-2017%22&limit=1).
Why it’s dangerous
The tablets have failed specifications for increased hardness. While the record does not specify a direct injury mechanism, harder tablets may not dissolve properly or could be difficult for children to chew and swallow safely.
Who’s affected
Parents or caregivers who purchased Children's Cetirizine Hydrochloride Chewable Tablets from Sun Pharmaceutical Industries between distribution dates leading up to April 18, 2017. The specific risk is limited to those with the affected lot number.
How to tell if you have this one
Check your bottle for the label 'Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count'. Verify the NDC is 47335-343-83 and the Lot # is JKR5135A with an expiration date of 11/17.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check your product details
Verify that your bottle matches the recalled NDC 47335-343-83 and Lot # JKR5135A.
Contact Sun Pharmaceutical
Since no specific remedy is listed in the record, contact Sun Pharmaceutical Industries directly for further instructions on what to do with the product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0857-2017 (April 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0857-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.