FDA Drug recall D-0355-2024
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbona…
- FDA Drug
- Class II
- completed
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class II recall of Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbona… by Bausch Health Companies, citing subpotent Drug: Out of specification for assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0355-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-02-02 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bausch Health Companies |
| Distribution | US |
Product
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.
Reason
Subpotent Drug: Out of specification for assay
Identifiers
| ndc | 68682-990-30 |
|---|---|
| ndc | 68682-991-30 |
| ndc | 68682-102-30 |
| ndc | 68682-104-30 |
| code_info | Lot #0013R; Exp. 01/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0355-2024%22
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