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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Oceanside Pharmaceuticals Omeprazole Suspension Recalled for Subpotency

Agency Publication Date: February 28, 2024
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Summary

Bausch Health Companies, Inc. is recalling 3,600 cartons of Omeprazole and Sodium Bicarbonate For Oral Suspension (40mg/1,680mg) distributed under the Oceanside Pharmaceuticals brand. The medication is being recalled because it was found to be subpotent, meaning it did not meet the required potency specifications during testing. If you have health concerns regarding this medication, contact your healthcare provider or pharmacist.

Risk

A subpotent drug contains less of the active ingredient than indicated on the label, which may result in a patient receiving an inadequate dose and failing to properly manage their medical condition. No specific injuries or adverse events were reported in the recall notice.

What You Should Do

  1. This recall affects Oceanside Pharmaceuticals Omeprazole and Sodium Bicarbonate For Oral Suspension (40mg/1,680mg) packets with Lot #0013R and an expiration date of 01/2026 (NDC 68682-991-30).
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Bausch Health Companies, Inc. for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Omeprazole and Sodium Bicarbonate For Oral Suspension (40mg/1,680mg)by Oceanside Pharmaceuticals
Variants: 40mg/1,680mg, Oral Suspension, Packet
Lot Numbers:
0013R (Exp 01/2026)
NDC:
68682-991-30

Distributed by Oceanside Pharmaceuticals; This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93911
Status: Resolved
Manufacturer: Bausch Health Companies, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 3,600 cartons
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.