Omeprazole and Sodium Bicarbonate Prescription Drug Recalled Due to Subpotency
Bausch Health Companies is recalling 3,600 cartons of Omeprazole and Sodium Bicarbonate nationwide. The drug was found to be subpotent, containing less active ingredient than specified.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for subpotent drug with no reported illnesses or injuries. The hazard is theoretical—patients may not receive the full therapeutic benefit—capped at severity level 3 per the rubric.
Plain-English summary
Bausch Health Companies, Inc. is recalling Omeprazole and Sodium Bicarbonate for Oral Suspension (40mg/1,680mg) due to subpotency. Testing found the product to be out of specification for assay, meaning the packets contain less omeprazole than the labeled 40 milligrams per dose.
The recall affects 3,600 cartons of Lot #0013R with an expiration date of January 2026. The medication was distributed nationwide. The product is distributed by Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, in Bridgewater, New Jersey (NDC 68682-991-30).
This recall has been classified by the FDA as Class II.
The recalled product
- Product
- OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE)
- Brand
- OMEPRAZOLE AND SODIUM BICARBONATE
- Manufacturer
- Bausch Health Companies, Inc.
- Category
- Drug — Proton Pump Inhibitor
- Hazard
- subpotency
- out-of-spec
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #0013R
- Exp. 01/2026
UPCs (2)
- 0368682102307
- 0368682104301
Distribution
Distributed nationwide across the United States.
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