Prescription Drug Esomeprazole Out of Specification for Potency
Sun Pharmaceutical is recalling Esomeprazole Magnesium capsules nationwide because the drug potency exceeds the specified level at the 12-month 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 Class III recall without reported illnesses or injuries. The hazard—out-of-specification drug potency—is a quality control issue without evidence of consumer harm.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg (NDC 63304-735-90). The recall affects 8,640 bottles distributed nationwide in the United States. The affected product was manufactured by Ohm Laboratories Inc.
The medication in lot AC14304 with expiration 12/2022 is being recalled because it is out of specification for assay—the drug potency exceeds the specified level at the 12-month timepoint. This is classified as a Class III recall.
Consumers who have obtained this medication should consult with their pharmacist or healthcare provider for guidance on the medication in their possession.
The recalled product
- Product
- ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Antacid
- Hazard
- over-potency
- specification-failure
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 AC14304
- Exp 12/2022.
UPCs (3)
- 0363304734300
- 0363304734904
- 0363304735307
Distribution
Distributed nationwide across the United States.
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- ModerateEsomeprazole Magnesium Capsules Recalled for Out-of-Specification Potency
FDA (Drugs) · 2022-10-05
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