FDA Drug recall D-0004-2023
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc
- FDA Drug
- Class III
- terminated
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class III recall of Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc by Sun Pharmaceutical Industries, citing superpotent Drug: Out of specification for assay at the 12-month timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0004-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-06-21 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Identifiers
| ndc | 63304-734-90 |
|---|---|
| ndc | 63304-734-30 |
| ndc | 63304-734-10 |
| ndc | 63304-735-90 |
| ndc | 63304-735-30 |
| ndc | 63304-735-10 |
| code_info | Lot AC14299, Exp 12/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Sun Pharmaceutical Industries recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0004-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.