Omeprazole Oral Oil Suspensions Recalled for Low Potency

Agency Publication Date: January 23, 2023

Summary

Wedgewood Village Pharmacy, LLC has recalled four veterinary oral oil suspensions containing Omeprazole, Aluminum Hydroxide, and Magnesium Hydroxide because they are subpotent. Testing revealed that the concentration of Omeprazole is lower than the labeled amount of 2 gm/30 mL, meaning animals may not receive the full intended dose of medication. While no injuries have been reported, about 4 units across several flavors and lot numbers are affected by this voluntary recall.

Risk

A subpotent drug may fail to effectively treat the animal's condition, such as gastric ulcers, because the active ingredient (Omeprazole) is weaker than what the veterinarian prescribed. This could lead to a recurrence or worsening of symptoms if the underlying condition is not properly managed.

What You Should Do

Check your medication container for the following lot numbers: 000-04543004, 000-04561112, 000-04561113, 000-04561123, 000-04561124, 000-04561126, 000-04543000, 000-04521426, 000-04526093, 000-04510021, or 000-04536665.
If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, throw it away, or contact Wedgewood Village Pharmacy, LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, or contact the manufacturer or supplier for further instructions

Option 2: Dispose of Product

How to: Throw the product away.

Affected Products

Product: Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide Banana/Marshmallow Oral Oil Suspension

Variants: 2gm/4gm/4gm/30ml, Banana/Marshmallow flavor

Model:

V-0042-2023

Lot Numbers:

000-04543004 (BUD: 05/16/2023)

Packaged in amber round plastic bottle.

Product: Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide Apple/Molasses Oral Oil Suspension (900 ml)

Variants: 2gm/4gm/4gm/30ml, Apple/Molasses flavor

Model:

V-0043-2023

Lot Numbers:

000-04561112 (BUD: 05/16/2023)

000-04561113 (BUD: 05/16/2023)

000-04561123 (BUD: 05/16/2023)

000-04561124 (BUD: 05/16/2023)

000-04561126 (BUD: 05/16/2023)

000-04543000 (BUD: 05/16/2023)

000-04521426 (BUD: 05/16/2023)

Packaged in amber round plastic bottle.

Product: Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide Peppermint Oral Oil Suspension (900 ml)

Variants: 2gm/4gm/4gm/30ml, Peppermint flavor

Model:

V-0044-2023

Lot Numbers:

000-04526093 (BUD: 05/16/2023)

Packaged in amber round plastic bottle.

Product: Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide Apple Oral Oil Suspension (900 ml)

Variants: 2gm/4gm/4gm/30ml, Apple flavor

Model:

V-0045-2023

Lot Numbers:

000-04510021 (BUD: 03/05/2023)

000-04536665 (BUD: 05/16/2023)

Packaged in amber round plastic bottle.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91469

Status: Active

Manufacturer: Wedgewood Village Pharmacy, LLC

Sold By: Wedgewood Village Pharmacy, LLC

Manufactured In: United States

Units Affected: 4 products (2 x 910 mL bottles; 1 x 910 mL bottle per lot; 1 x 910 mL bottle; Lot # 000-04510021 (1 x 289 mL bottle); Lot # 000-04536665 (1 x 910 mL bottle))

Distributed To: California, Maryland, Minnesota, New Jersey, New York, Pennsylvania

Agency Last Updated: January 30, 2023

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 · Raw API Response

Summary

What You Should Do

Check your medication container for the following lot numbers: 000-04543004, 000-04561112, 000-04561113, 000-04561123, 000-04561124, 000-04561126, 000-04543000, 000-04521426, 000-04526093, 000-04510021, or 000-04536665.

If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, throw it away, or contact Wedgewood Village Pharmacy, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

Option 2: Dispose of Product

How to: Throw the product away.

Affected Products

Product: Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide Banana/Marshmallow Oral Oil Suspension

Variants: 2gm/4gm/4gm/30ml, Banana/Marshmallow flavor

Model:

V-0042-2023

Lot Numbers:

000-04543004 (BUD: 05/16/2023)

Packaged in amber round plastic bottle.

Product: Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide Apple/Molasses Oral Oil Suspension (900 ml)

Variants: 2gm/4gm/4gm/30ml, Apple/Molasses flavor

Model:

V-0043-2023

Lot Numbers:

000-04561112 (BUD: 05/16/2023)

000-04561113 (BUD: 05/16/2023)

000-04561123 (BUD: 05/16/2023)

000-04561124 (BUD: 05/16/2023)

000-04561126 (BUD: 05/16/2023)

000-04543000 (BUD: 05/16/2023)

000-04521426 (BUD: 05/16/2023)

Packaged in amber round plastic bottle.

Product: Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide Peppermint Oral Oil Suspension (900 ml)

Variants: 2gm/4gm/4gm/30ml, Peppermint flavor

Model:

V-0044-2023

Lot Numbers:

000-04526093 (BUD: 05/16/2023)

Packaged in amber round plastic bottle.

Product: Omeprazole/Aluminum Hydroxide/Magnesium Hydroxide Apple Oral Oil Suspension (900 ml)

Variants: 2gm/4gm/4gm/30ml, Apple flavor

Model:

V-0045-2023

Lot Numbers:

000-04510021 (BUD: 03/05/2023)

000-04536665 (BUD: 05/16/2023)

Packaged in amber round plastic bottle.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91469

Status: Active

Manufacturer: Wedgewood Village Pharmacy, LLC

Sold By: Wedgewood Village Pharmacy, LLC

Manufactured In: United States

Units Affected: 4 products (2 x 910 mL bottles; 1 x 910 mL bottle per lot; 1 x 910 mL bottle; Lot # 000-04510021 (1 x 289 mL bottle); Lot # 000-04536665 (1 x 910 mL bottle))

Distributed To: California, Maryland, Minnesota, New Jersey, New York, Pennsylvania

Agency Last Updated: January 30, 2023