Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0005-2023·Announced 2022-10-05

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.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units: 8,640

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.

Part of a larger recall action

This product is one of 2 recalled by SUN PHARMACEUTICAL INDUSTRIES INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same brand · ESOMEPRAZOLE MAGNESIUM

Moderate
Esomeprazole Magnesium oral suspension recalled for failed impurity specifications
FDA (Drugs) · 2025-05-28
Severe
Esomeprazole Magnesium Oral Suspension Recalled for Failed Impurity Specifications
FDA (Drugs) · 2025-05-28
Moderate
Prescription drug esomeprazole magnesium recalled for labeling error
FDA (Drugs) · 2024-12-11
Moderate
Prescription esomeprazole magnesium capsules recalled for failed impurity specifications
FDA (Drugs) · 2023-11-29
Moderate
Esomeprazole Magnesium Capsules Recalled for Out-of-Specification Potency
FDA (Drugs) · 2022-10-05

Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC

See all →

Low
Sun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
Low
Sun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
Low
Sun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
High
Sun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
Low
Fexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08

Same hazard · over potency