Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1 (Omeprazole, Sodium Bicarbonate)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug: Out of specification for assay
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was 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.
Affected NDC
68682-0991-30
Compare with the code on your package — it is the most precise check available.
Drug: Omeprazole Category: Heartburn & Stomach Medication
- Recalling firm
- Bausch Health Companies, Inc.
- NDC code
- 68682-991-30
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0355-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Omeprazole recalls
See all
Class II · Moderate risk
Good Sense Omeprazole Tablet 14ct Sku 900055 Prilosec OTC…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class II · Moderate risk
Omeprazole Delayed Release Capsules
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Class II · Moderate risk
Prilosec (Omeprazole Magnesium)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Bausch Health Companies, Inc.
All 2024 recalls
Class III · Low risk
Phytonadione Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Mephyton (Phytonadione)
Failed Impurities/Degradation Specifications
Class III · Low risk
Phytonadione Tablets 5mg
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Class III · Low risk
Mephyton (phytonadione)
Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
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