Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1 — Class II drug recall D-0355-2024
Completed recall by Bausch Health Companies, Inc., reported 2024-03-06, distributed nationwide. Subpotent Drug: Out of specification for assay
| Recall number | D-0355-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch Health Companies, Inc., Bridgewater, NJ, United States |
| Recall initiated | 2024-02-02 |
| Classified | 2024-02-28 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 3,600 cartons |
| Reason classes | potency, specification failure |
| NDC | 68682-0102, 68682-0102-30, 68682-0104, 68682-0104-30, 68682-0990, 68682-0990-30, 68682-0991, 68682-0991-30 |
| Lot numbers | 0013R |
| Expiration dates | 2026-01 |
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 for recall
Subpotent Drug: Out of specification for assay
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-0355-2024. 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.