CLASS II Drug recall · Reported 6 Mar 2024 · FDA Enforcement Report
Omeprazole and Sodium Bicarbonate For Oral Suspension recalled
Bausch Health Companies is recalling Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains, distributed nationwide in the US. The recall was initiated on 2 Feb 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0355-2024
- FDA event ID
- 93911
- Recalling firm
- Bausch Health Companies, Bridgewater, NJ
- Manufacturer
- Oceanside Pharmaceuticals
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 2 Feb 2024
- FDA classified
- 28 Feb 2024
- Reported
- 6 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 2 Feb 2024 | Recall initiated by company | |
| 28 Feb 2024 | Classified by FDA | +26 days |
| 6 Mar 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Out of specification for assay
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug: Out of specification for assay
Which lots are affected?
Lot #0013R; Exp. 01/2026
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bausch Health Companies
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|---|---|---|---|---|---|
| Drug | CLASS III | Phytonadione Tablets, 5 mg ablets recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS III | Mephyton (Phytonadione) recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS III | Mephyton (phytonadione) Tablets 5mg recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS III | Phytonadione Tablets 5mg recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone butyrate Cream, 0.1% tubes recalled | Bausch Health Companies | Potency & Assay | Nationwide |
Other Omeprazole recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-Release Capsules, 20 mg* recalledAcid Reducer | Dr. Reddy's Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Prilosec (Omeprazole Magnesium) For Delayed-Release Oral recalledPrilosec | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Omeprazole Delayed Release Capsules, USP, 20 mg recalled | Golden State Medical Supply | Potency & Assay | PA, TX |
| Drug | CLASS II | Omeprazole Delayed-Release Capsules, USP, 20 mg recalled | Breckenridge Pharmaceutical | Potency & Assay | Nationwide |