Phenylbutazone 1 gram Boluses Recalled for Formulation Error

Agency Publication Date: June 9, 2021

Summary

First Priority, Inc. is recalling approximately 84,554 bottles of Phenylbutazone (1 gram) boluses used as a non-steroidal anti-inflammatory drug for horses. The recall was initiated because the product was manufactured using sodium alginate instead of the required alginic acid. This formulation error may affect the drug's performance or stability. No incidents or injuries have been reported to date.

Risk

The use of an incorrect inactive ingredient (sodium alginate instead of alginic acid) could potentially alter how the medication is absorbed or how the bolus dissolves, which may lead to reduced effectiveness in treating inflammation in horses.

What You Should Do

Check your Phenylbutazone bolus bottles for the following brands: Priority Care, Vedco, Henry Schein Animal Health, MWI, or Covetrus North America.
Verify if your product is affected by checking the lot number and expiration date printed on the bottle. See the Affected Products section below for the full list of affected codes.
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 the manufacturer or supplier for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for 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: Phenylbutazone, USP, 1 gram Boluses (100 count)

Variants: For Oral Use in Horses Only

UPC Codes:

840066500966

362308334103

350989698515

313985011726

Lot Numbers:

F4L (Exp 05/21)

F7L (Exp 05/21)

H9L (Exp 07/21)

Hl2L (Exp 07/21)

12L (Exp 08/21)

13L (Exp 08/21)

I4L (Exp 08/21)

I25L (Exp 08/21)

K9L (Exp 10/21)

K13L (Exp 10/21)

Kl6L (Exp 10/21)

D12M (Exp 03/22)

Dl3M (Exp 03/22)

F12M (Exp 05/22)

Fl3M (Exp 05/22)

H35M (Exp 07/22)

H39M (Exp 07/22)

135M (Exp 08/22)

139M (Exp 08/22)

K6M (Exp 10/22)

Kl OM (Exp 10/22)

K30M (Exp 10/22)

L5M (Exp 11/22)

Ll4M (Exp 11/22)

A20N (Exp 12/22)

A23N (Exp 12/22)

A24N (Exp 12/22)

A38N (Exp 12/22)

Bl6N (Exp 01/23)

B20N (Exp 01/23)

B31N (Exp 01/23)

NDC:

58829-334-1

50989-689-51

11695-2206-1

13985-565-01

11695-2213-1

Distributed under multiple labels: Priority Care, Vedco, Henry Schein, MWI, and Covetrus.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88049

Status: Resolved

Manufacturer: First Priority, Inc.

Sold By: Vedco, Inc.; Henry Schein Animal Health; MWI; Covetrus North America

Manufactured In: United States

Units Affected: 84,554 bottles

Distributed To: New Jersey, Ohio, Missouri, Iowa, Kansas, Puerto Rico

Agency Last Updated: June 17, 2021

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 Phenylbutazone bolus bottles for the following brands: Priority Care, Vedco, Henry Schein Animal Health, MWI, or Covetrus North America.

Verify if your product is affected by checking the lot number and expiration date printed on the bottle. See the Affected Products section below for the full list of affected codes.

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 the manufacturer or supplier for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for 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: Phenylbutazone, USP, 1 gram Boluses (100 count)

Variants: For Oral Use in Horses Only

UPC Codes:

840066500966

362308334103

350989698515

313985011726

Lot Numbers:

F4L (Exp 05/21)

F7L (Exp 05/21)

H9L (Exp 07/21)

Hl2L (Exp 07/21)

12L (Exp 08/21)

13L (Exp 08/21)

I4L (Exp 08/21)

I25L (Exp 08/21)

K9L (Exp 10/21)

K13L (Exp 10/21)

Kl6L (Exp 10/21)

D12M (Exp 03/22)

Dl3M (Exp 03/22)

F12M (Exp 05/22)

Fl3M (Exp 05/22)

H35M (Exp 07/22)

H39M (Exp 07/22)

135M (Exp 08/22)

139M (Exp 08/22)

K6M (Exp 10/22)

Kl OM (Exp 10/22)

K30M (Exp 10/22)

L5M (Exp 11/22)

Ll4M (Exp 11/22)

A20N (Exp 12/22)

A23N (Exp 12/22)

A24N (Exp 12/22)

A38N (Exp 12/22)

Bl6N (Exp 01/23)

B20N (Exp 01/23)

B31N (Exp 01/23)

NDC:

58829-334-1

50989-689-51

11695-2206-1

13985-565-01

11695-2213-1

Distributed under multiple labels: Priority Care, Vedco, Henry Schein, MWI, and Covetrus.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88049

Status: Resolved

Manufacturer: First Priority, Inc.

Sold By: Vedco, Inc.; Henry Schein Animal Health; MWI; Covetrus North America

Manufactured In: United States

Units Affected: 84,554 bottles

Distributed To: New Jersey, Ohio, Missouri, Iowa, Kansas, Puerto Rico

Agency Last Updated: June 17, 2021