Esomeprazole Magnesium Delayed-Release Capsules — Class III drug recall D-0004-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-10-05, distributed nationwide. Superpotent Drug: Out of specification for assay at the 12-month timepoint.
| Recall number | D-0004-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2022-06-21 |
| Classified | 2022-10-06 |
| Reported by FDA | 2022-10-05 |
| Terminated | 2023-08-11 |
| Distributed | Nationwide (US) |
| Quantity | 5,712 bottles |
| Reason classes | potency, specification failure |
| NDC | 63304-0734, 63304-0734-10, 63304-0734-30, 63304-0734-90, 63304-0735, 63304-0735-10, 63304-0735-30, 63304-0735-90 |
| Lot numbers | AC14299 |
| Expiration dates | 2022-12 |
Product
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.
Reason for recall
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0004-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.