Use caution Drug recall · FDA · Published April 15, 2015

Sandoz Recalls Cetirizine Chewable Tablets Due to Impurity Issues

Sandoz recalls over 1 million units of Cetirizine HCl chewable tablets due to failed impurity specifications. Check lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1115-2015Drug Sandoz ›

Use caution until it’s fixed

Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.

Take action

Contact the company

Recalling firmSandoz, Inc506 Carnegie Ctr Ste 400 · Princeton, NJ 08540-6243

✎ GovInfoNow plain-language explainer

Sandoz, Inc. is recalling specific lots of Cetirizine HCl Chewable Tablets, 10 mg, because they failed impurity specifications at the 21-month stability test point. The recall affects units distributed nationwide with expiration dates in May and July 2015. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/44789-sandoz-inc-recalls-cetirizine-hcl-chewable-tablet-10-mg-6.

Source Summary by GovInfoNow · govinfonow.com/recall/44789-sandoz-inc-recalls-cetirizine-hcl-chewable-tablet-10-mg-6 · Updated October 12, 2026 · FDA enforcement record: FDA #D-1115-2015

Cite this page

“Sandoz Recalls Cetirizine Chewable Tablets Due to Impurity Issues.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44789-sandoz-inc-recalls-cetirizine-hcl-chewable-tablet-10-mg-6. Based on FDA recall #D-1115-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1115-2015%22&limit=1).

The FDA announced on April 15, 2015, that Sandoz Inc. is recalling Cetirizine HCl Chewable Tablets due to failed impurity specifications. Owners should contact Sandoz for a refund.

How to tell if you have it

Brand: Sandoz
Product: Cetirizine HCl Chewable Tablet, 10 mg
Packaging: 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations
NDC: 66394-041-06
Lot codes: DP3841, DP5237, DP5238, DP5238A, DP5238B (Exp 05/2015); DR7807, DR9954, DR9959, DV5838 (Exp 07/2015)
Distribution: Nationwide
Units affected: 1,023,430

The hazard

The recall is due to an out-of-specification result for impurities at the 21-month stability time point. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Sandoz Inc has had 29 other recalls on record since October 9, 2013. Other recent recalls of similar products include Sandoz Focalin XR 5mg Capsules (June 1, 2026), Sandoz Cyclophosphamide Injection (September 5, 2025), and Sandoz Ciprofloxacin Otic Suspension (August 13, 2025). Other recent recalls of similar products include Rising Pharma Temozolomide 5mg Capsules (March 3, 2026), Unichem Bisoprolol/Hydrochlorothiazide Tablets (January 21, 2026), and Novadoz Glycopyrrolate Oral Solution (December 15, 2025).

How to tell if you have this one

Check your bottle for the brand Sandoz and the product name Cetirizine HCl Chewable Tablet, 10 mg. Look for NDC 66394-041-06 and one of the following lot numbers: DP3841, DP5237, DP5238, DP5238A, DP5238B (Exp 05/2015) or DR7807, DR9954, DR9959, DV5838 (Exp 07/2015). The product was distributed nationwide.

Brand
Sandoz
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Lot Numbers
Compare the lot numbers and expiration dates on your medication bottle against the recalled list provided in the record.
Contact Sandoz for Instructions
Since no remedy is stated in the record, contact Sandoz directly to inquire about returns or replacements for the affected lots.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

Apr 15, 2015Firm started the recall
Jun 3, 2015FDA classified it Class III
Jun 10, 2015Published in FDA’s Enforcement Report
Oct 5, 2016FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where was this product sold?

The product was distributed nationwide across the United States.

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Link to this recall

<a href="https://govinfonow.com/recall/44789-sandoz-inc-recalls-cetirizine-hcl-chewable-tablet-10-mg-6">Sandoz Recalls Cetirizine Chewable Tablets Due to Impurity Issues (GovInfoNow)</a>

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-1115-2015 (April 15, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1115-2015 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.