Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1 recall
FDA recall D-0355-2024 · initiated Feb 2, 2024
Bausch Health Companies, Inc. recalled Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1 in Feb 2024 — an FDA Class II recall (D-0355-2024) because Subpotent Drug: Out of specification for assay.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug: Out of specification for assay
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3,600 cartons
Details
- 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.
- Recalling company
- Bausch Health Companies, Inc.
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Feb 2, 2024
- FDA report date
- Mar 6, 2024
Frequently asked
- Was Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1 recalled?
- Bausch Health Companies, Inc. recalled Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1 in Feb 2024 — an FDA Class II recall (D-0355-2024) because Subpotent Drug: Out of specification for assay. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1 recalled?
- Per the FDA enforcement record, the reason for recall D-0355-2024 was: Subpotent Drug: Out of specification for assay
- Is a recalled Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1 dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1 are affected?
- Distributed: Nationwide. The recall covers these lots — Lot #0013R; Exp. 01/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0355-2024.