Prescription esomeprazole magnesium capsules recalled for failed impurity specifications
Glenmark Pharmaceuticals recalled esomeprazole magnesium 20mg capsules nationwide due to out-of-specification organic impurities detected during stability testing. No illnesses have been reported.
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: This is an FDA Class III recall of a prescription drug due to out-of-specification organic impurities detected during stability testing. No illnesses or injuries have been reported. Per FDA guidance, Class III recalls are typically scored as 1 or 2; the presence of a quality-control failure warrants a Moderate score rather than Low.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling esomeprazole magnesium delayed-release capsules, USP 20mg (Lot 17220002, expiration date 11/30/2023) nationwide in the United States.
The recall was initiated because testing of the drug product at the 18-month timepoint in a long-term stability study (25°C/60% RH) identified an out-of-specification result for organic impurities, meaning the impurity levels exceeded the acceptable limits established for the product.
The recalled products include 8,448 bottles of 30-count capsules (NDC 68462-390-30) and 168 bottles of 1,000-count capsules (NDC 68462-390-10). These products were manufactured by Glenmark Pharmaceuticals Inc., USA and distributed nationwide.
Consumers currently taking esomeprazole magnesium from the affected lot should consult their healthcare provider or pharmacist. No illnesses or adverse events related to this product have been reported.
The recalled product
- Product
- ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- organic-impurities
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 (2)
- Lot # 17220002
- Exp Date 11/30/2023
UPCs (2)
- 0368462391303
- 0368462390306
Distribution
Distributed nationwide across the United States.
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