Lower riskDrug recall · FDA · Published February 2, 2024
Bausch Health Omeprazole Suspension Recall: Subpotent Drug Risk
Bausch Health recalls Omeprazole and Sodium Bicarbonate Oral Suspension 40mg/1,680mg due to subpotent drug levels. This may not provide intended treatment. Contact for return instructions.
“Bausch Health Omeprazole Suspension Recall: Subpotent Drug Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32838-bausch-health-omeprazole-suspension-recall-subpotent-drug-risk. Based on FDA recall #D-0355-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0355-2024%22&limit=1).
The FDA announced on Feb. 2, 2024, that Bausch Health Companies, Inc. is recalling Omeprazole and Sodium Bicarbonate For Oral Suspension due to subpotent drug risks. The agency classified the recall as Class II.
How to tell if you have it
Brand: Bausch Health
Product: Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg
NDC: 68682-991-30
Lot #: 0013R
Expiration: 01/2026
The hazard
The recall addresses a subpotent drug hazard caused by the product being out of specification for assay. This means the packets may contain less omeprazole than labeled.
Context
GovInfoNow's records show Bausch Health Companies, Inc. has had three other recalls since July 13, 2020. Other recent recalls of similar products include Unichem busPIRone 5mg Tablets Recall (April 13, 2026), Gasco Isopropyl Alcohol 70% Recall (May 29, 2026), and Bell Pharmaceuticals Carbamide Peroxide 6.5% Recall (June 25, 2026).
How to tell if you have this one
Check for the product name 'Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg' with lot number 0013R. It was distributed by Oceanside Pharmaceuticals in Bridgewater, NJ.
Brand
Bausch Health
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number 0013R on the packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0355-2024 (February 2, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0355-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.