Allopurinol tablets recalled due to improper storage conditions
Cardinal Healthcare is recalling Allopurinol 300 MG tablets (batch L100813) nationwide because products were exposed to temperatures outside their labeled storage conditions. Patients should consult their healthcare provider.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall without reported illnesses or injuries. The hazard is precautionary; temperature exposure to the product could affect stability, but no documented patient harm has occurred. Score reflects manufacturing deviation severity balanced against absence of reported patient impact.
Plain-English summary
Allopurinol 300 MG tablets, batch L100813, manufactured by Dr. Reddy's Laboratories and distributed by Cardinal Healthcare, are being recalled nationwide. The recall was initiated due to a manufacturing deviation where products were exposed to temperatures outside the storage conditions specified on the product label.
This temperature exposure represents a Current Good Manufacturing Practice (CGMP) deviation. Temperature-sensitive pharmaceuticals can potentially lose potency or develop degradation products when stored outside recommended conditions, though the specific impact on this product has not been detailed in the recall notice.
Patients who have received this product should consult their healthcare provider or pharmacist regarding their allopurinol supply. Allopurinol is used to manage gout and reduce uric acid levels, so patients should not discontinue use without medical guidance. Healthcare providers and pharmacies should check their inventory against batch L100813 and remove affected product from distribution.
The recalled product
- Product
- ALLOPURINOL (ALLOPURINOL)
- Brand
- ALLOPURINOL
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug
- Hazard
- temperature-exposure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch L100813
UPCs (2)
- 0355111729013
- 0355111730019
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ALLOPURINOL
- HighAllopurinol tablets recalled due to presence of foreign substance
FDA (Drugs) · 2024-07-10
- HighAllopurinol Tablets Recalled for Green Plastic Contamination
FDA (Drugs) · 2023-02-01
Same category
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22