Sun Pharmaceutical AllerClear D-24 hr Tablets Recall: Failed Moisture Limits
Sun Pharmaceutical recalls AllerClear D-24 hr tablets due to failed moisture limits. This may cause reduced effectiveness or safety issues. Check your product for the NDC 63981-724-15 label.
Lower-risk recall
Failed Moisture Limits
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What happened, in plain English
Sun Pharmaceutical is recalling Aller:Clear D-24 hr tablets because they failed moisture limits. This could mean the medication doesn't work as intended or poses safety risks. Affected products were sold between November 2022 and the current date. Read more at govinfonow.com/recall/35710-sun-pharmaceutical-allerclear-d-24-hr-tablets-recall-failed-moisture.
Source Summary by GovInfoNow · govinfonow.com/recall/35710-sun-pharmaceutical-allerclear-d-24-hr-tablets-recall-failed-moisture · Updated August 18, 2026 · FDA enforcement record: FDA #D-0069-2022
Cite this page
“Sun Pharmaceutical AllerClear D-24 hr Tablets Recall: Failed Moisture Limits.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35710-sun-pharmaceutical-allerclear-d-24-hr-tablets-recall-failed-moisture. Based on FDA recall #D-0069-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0069-2022%22&limit=1).
Why it’s dangerous
The tablets failed moisture limits, which means they may not work properly or could become unsafe. This could lead to reduced effectiveness of the medication or potential safety issues if the tablets degrade over time.
Who’s affected
People who own or use AllerClear D-24 hr tablets with the NDC 63981-724-15 label are affected. Those with allergies or respiratory conditions may be at higher risk due to potential reduced effectiveness.
How to tell if you have this one
Check for the NDC code 63981-724-15 on the blister pack. Products were manufactured by Ohm Laboratories Inc. in North Brunswick, NJ, starting November 2022.
- Brand
Sun Pharmaceutical Industries- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0068-2022 | Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15; Lot #: AC14635, Exp. Date 12/2022 | 22,752 blister packs | 0904-5833-15, 0904-5833-48 |
| D-0069-2022 | AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15; AC09723, Exo, Date 11/2022 | 46,584 blister packs | 63981-724-15 |
What to do — step by step
Check Product Label
Look for the NDC code 63981-724-15 on the blister pack to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 23 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.
Questions people ask
Is there a risk of serious injury from this product?
The recall is due to failed moisture limits, which may affect effectiveness but not pose a serious injury risk.
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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-0069-2022 (October 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0069-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.