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Class II Recall — Risk of Temporary or Reversible Adverse Health Consequences
Verified · FDAClass II — Possible RiskMedications

OMEPRAZOLE AND SODIUM BICARBONATE Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet Recall 2024

OMEPRAZOLE AND SODIUM BICARBONATEIssued February 2, 2024

OMEPRAZOLE AND SODIUM BICARBONATE 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 c — recalled per FDA on 2/2/2024. Reason: Subpotent Drug: Out of specification for assay.

Issuing agency
FDA
Issued
Feb 2, 2024
Brand
OMEPRAZOLE AND SODIUM BICARBONATE
Distribution
1 states

What to do right now

  1. 1

    Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. 2

    Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. 3

    Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

Verified source

U.S. Food and Drug Administration

Summary of the official FDA notice issued February 2, 2024. Last synced Apr 27, 2026. View on fda.gov

What's recalled

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.

Why it was recalled

Subpotent Drug: Out of specification for assay

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot #0013R
Exp. 01/2026
Where was it sold
1 state

Nationwide

nationwide
View official FDA notice

View all questions for this recall →

More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the OMEPRAZOLE AND SODIUM BICARBONATE recall still active?

Yes, this recall is currently active as of February 2, 2024. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot #0013R, Exp. 01/2026. Check the label on your product.

What should I do if I have the recalled OMEPRAZOLE AND SODIUM BICARBONATE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.