Sun Pharmaceutical Esomeprazole Capsules Recall: Superpotent Drug Risk
Sun Pharmaceutical recalls 20mg esomeprazole capsules due to superpotent drug levels. This may cause serious health effects if taken as prescribed. Consumers should contact the manufacturer for details.
Recall notice
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Contact the company
What happened, in plain English
Sun Pharmaceutical is recalling 20mg esomeprazole capsules that may be too strong. This could cause serious health issues if taken as directed. Affected products were manufactured by Ohm Laboratories and distributed by Sun Pharmaceutical. Read more at govinfonow.com/recall/34611-sun-pharmaceutical-esomeprazole-capsules-recall-superpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/34611-sun-pharmaceutical-esomeprazole-capsules-recall-superpotent-drug-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0004-2023
Cite this page
“Sun Pharmaceutical Esomeprazole Capsules Recall: Superpotent Drug Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/34611-sun-pharmaceutical-esomeprazole-capsules-recall-superpotent-drug-risk. Based on FDA recall #D-0004-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0004-2023%22&limit=1).
Why it’s dangerous
The capsules were found to have higher-than-specified drug levels at the 12-month mark. This means they could be significantly more potent than intended, potentially causing serious health effects if taken as prescribed.
Who’s affected
People who have the specific 20mg esomeprazole capsules with NDC 63304-734-90 and lot number AC14299 are affected. Prescriptions for this medication are typically for those with acid reflux or ulcers.
How to tell if you have this one
Check for the product name 'Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle'. Look for the lot number AC14299 and expiration date 12/2022 on the packaging.
- Brand
Sun Pharmaceutical- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide in the USA- NDC
63304-734-90, 63304-734-30, 63304-734-10, 63304-735-90, 63304-735-30, 63304-735-10
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0004-2023 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.; Lot AC14299, Exp 12/2022 | 5712 bottles |
| D-0005-2023 | Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.; Lot AC14304, Exp 12/2022. | 8640 bottles |
What to do — step by step
Check Product Details
Look for the lot number AC14299 and expiration date 12/2022 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class III
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall record states the product may be too strong, so it is not safe to use as intended without further instructions.
Similar recalls
Other Sun Pharmaceutical recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0004-2023 (June 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0004-2023 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.