Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported October 24, 2012
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Sandoz Incorporated recalled Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in I… - a low-severity action.
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in I… was recalled by Sandoz Incorporated in October 24, 2012. Reason: Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin est…. Check the official notice for the remedy. Verify recall #D-008-2013 with the FDA Drug before acting.
The recall
Sandoz Incorporated issued this low-severity FDA Drug recall-Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin est….
- Low
- severity level
- Class III
- classification
- October 24, 2012
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-008-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-008-2013) was formally reported on October 24, 2012, with the manufacturer initiating the action on September 20, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Sandoz Incorporated is listed as the recalling firm, operating out of Broomfield, CO. Federal records list the affected scope as 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons.
The documented reason for this recall is: Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2) Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
Related Recalls
6
5 from same agency
Product description
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33
Reason for recall
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-008-2013 |
| Date reported | October 24, 2012 |
| Date initiated | September 20, 2012 |
| Recalling firm | Sandoz Incorporated |
| Firm location | Broomfield, CO |
| Affected scope | 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-008-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33. Recalled by Sandoz Incorporated. Units affected: 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons.
Why was this product recalled? ▼
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 24, 2012. Severity: Low. Recall number: D-008-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-008-2013) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 24, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.