The Recall Desk
ModerateFDA (Drugs)·D-0004-2023·Announced 2022-10-05

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
Category
Drug — Prescription / Proton Pump Inhibitor
Hazard
Affected units
5,712

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.

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 →

Related recalls

Same brand · ESOMEPRAZOLE MAGNESIUM

Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC

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Same hazard · potency deviation

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