Esomeprazole Magnesium Capsules Recalled for Out-of-Specification Potency
Sun Pharmaceutical is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg nationwide due to superpotency findings. Lot AC14299 (expiration 12/2022) tested out of specification for drug assay at the 12-month stability timepoint.
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 classified this recall as Class III, which indicates the product is not likely to cause adverse health consequences. No illnesses or injuries have been reported. The issue is a pharmaceutical quality defect identified through stability testing rather than through patient harm.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg (NDC 63304-734 and 63304-735) distributed nationwide in the United States. The recall affects lot AC14299 with an expiration date of December 2022.
The product was found to be out of specification for drug assay during stability testing conducted at the 12-month timepoint. Specifically, the recalled capsules tested as superpotent, meaning the actual concentration of the active ingredient exceeded the amount specified in the product's approved formulation.
Approximately 5,712 bottles of the recalled lot were distributed nationwide. The product was manufactured by Ohm Laboratories Inc., New Brunswick, NJ, and distributed by Sun Pharmaceutical Industries Inc., Cranbury, NJ. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Hazard
- potency-deviation
- out-of-specification
- quality-defect
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 AC14299
- Exp 12/2022
UPCs (3)
- 0363304734300
- 0363304734904
- 0363304735307
Distribution
Distributed nationwide across the United States.
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