Virbac AH, Inc: Various Pet Shampoos and Gels Recalled for Incorrect Potency Levels

Agency Publication Date: November 12, 2015

Summary

Virbac AH, Inc. is recalling approximately 123,120 units of Etiderm Shampoo, Pyoben Gel, Pyoben Shampoo, and Resiketochlor Leave-on Lotion used for dogs, cats, and horses. These products are being recalled because their active ingredients (ethyl lactate, benzoyl peroxide, chlorhexidine gluconate, and ketoconazole) failed to maintain the correct strength throughout their shelf life, resulting in either too much or too little medication in the product. These veterinary skin treatments were distributed nationwide in the United States, Puerto Rico, Mexico, and Taiwan through various veterinary supply channels.

Risk

Products with low potency may fail to effectively treat the skin conditions for which they were prescribed, while high potency products (specifically the Pyoben Gel) may cause unexpected skin irritation or adverse reactions in pets. While no specific injuries were reported, the lack of chemical stability means the medication may not work as intended for the animal's health.

What You Should Do

Identify if you have the affected products by checking the brand name and the specific lot numbers and expiration dates printed on the bottles.
For Virbac Etiderm (8 oz or 16 oz), check for lot 130690 (Exp 05/2015), lot 131172 (Exp 09/2015), lot 131443 (Exp 11/2015), or lot 140194 (Exp 01/2016).
For Virbac Pyoben Gel (1 oz), check for lot 130622 (Exp 05/2015); for Pyoben Shampoo (8 oz or 16 oz), check for lot 131197 (Exp 10/2015) or lot 140150 (Exp 01/2016).
For Virbac Resiketochlor Lotion (8 oz), check for lots 130617 (Exp 05/2015), 130783 (Exp 06/2015), 131148 (Exp 09/2015), 131224 (Exp 10/2015), 140010 (Exp 12/2015), 140209 (Exp 02/2016), 140349 (Exp 03/2016), 140713 (Exp 06/2016), 140886 (Exp 07/2016), or 141146 (Exp 09/2016).
Contact your veterinarian or pharmacist for guidance on alternative treatments and to report any concerns about your pet's health.
Return any unused or remaining product to the place of purchase or pharmacy for a refund and contact Virbac AH, Inc. at their Fort Worth, Texas headquarters for further instructions.
For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

Full Refund

Drug product return for refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Virbac Etiderm (Ethyl Lactate 10% w/w) Shampoo (8 oz)

Model:

NDC 051311-080-08

Lot Numbers:

130690 (Exp 05/2015)

131172 (Exp 09/2015)

131443 (Exp 11/2015)

140194 (Exp 01/2016)

Date Ranges: May 2015, September 2015, November 2015, January 2016

Product: Virbac Etiderm (Ethyl Lactate 10% w/w) Shampoo (16 oz)

Model:

NDC 051311-080-16

Lot Numbers:

130690 (Exp 05/2015)

131172 (Exp 09/2015)

131443 (Exp 11/2015)

140194 (Exp 01/2016)

Date Ranges: May 2015, September 2015, November 2015, January 2016

Product: Virbac Pyoben Gel (Benzoyl Peroxide 3% w/w) (1 oz)

Model:

NDC 051311-014-30

Lot Numbers:

130622 (Exp 05/2015)

Date Ranges: May 2015

Product: Virbac Pyoben Shampoo (Benzoyl Peroxide 3% w/w) (8 oz)

Model:

NDC 0151311-012-08

Lot Numbers:

131197 (Exp 10/2015)

140150 (Exp 01/2016)

Date Ranges: October 2015, January 2016

Product: Virbac Pyoben Shampoo (Benzoyl Peroxide 3% w/w) (16 oz)

Model:

NDC 051311-012-16

Lot Numbers:

131197 (Exp 10/2015)

140150 (Exp 01/2016)

Date Ranges: October 2015, January 2016

Product: Virbac Resiketochlor (Chlorhexidine Gluconate 2.3% w/w; ketoconazole 1% w/w) Leave-on Lotion (8 oz)

Model:

NDC 0151311-780-08

Lot Numbers:

130617 (Exp 05/2015)

130783 (Exp 06/2015)

131148 (Exp 09/2015)

131224 (Exp 10/2015)

140010 (Exp 12/2015)

140209 (Exp 02/2016)

140349 (Exp 03/2016)

140713 (Exp 06/2016)

140886 (Exp 07/2016)

141146 (Exp 09/2016)

Date Ranges: May 2015, June 2015, September 2015, October 2015, December 2015, February 2016, March 2016, June 2016, July 2016, September 2016

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71194

Status: Resolved

Manufacturer: Virbac AH, Inc

Sold By: Veterinarians; Pet specialty retailers

Manufactured In: United States

Units Affected: 4 products (17,352 /8 oz. bottles; 13,320 /16 oz. bottles; 6,840 /1 oz. bottles; 28,656 /8 oz.bottles; 19,980 /16 oz. bottles; 70,272 /8oz. bottles)

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 · Raw API Response

Summary

Risk

What You Should Do

Identify if you have the affected products by checking the brand name and the specific lot numbers and expiration dates printed on the bottles.

For Virbac Etiderm (8 oz or 16 oz), check for lot 130690 (Exp 05/2015), lot 131172 (Exp 09/2015), lot 131443 (Exp 11/2015), or lot 140194 (Exp 01/2016).

For Virbac Pyoben Gel (1 oz), check for lot 130622 (Exp 05/2015); for Pyoben Shampoo (8 oz or 16 oz), check for lot 131197 (Exp 10/2015) or lot 140150 (Exp 01/2016).

For Virbac Resiketochlor Lotion (8 oz), check for lots 130617 (Exp 05/2015), 130783 (Exp 06/2015), 131148 (Exp 09/2015), 131224 (Exp 10/2015), 140010 (Exp 12/2015), 140209 (Exp 02/2016), 140349 (Exp 03/2016), 140713 (Exp 06/2016), 140886 (Exp 07/2016), or 141146 (Exp 09/2016).

Contact your veterinarian or pharmacist for guidance on alternative treatments and to report any concerns about your pet's health.

Return any unused or remaining product to the place of purchase or pharmacy for a refund and contact Virbac AH, Inc. at their Fort Worth, Texas headquarters for further instructions.

For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Affected Products

Product: Virbac Etiderm (Ethyl Lactate 10% w/w) Shampoo (8 oz)

Model:

NDC 051311-080-08

Lot Numbers:

130690 (Exp 05/2015)

131172 (Exp 09/2015)

131443 (Exp 11/2015)

140194 (Exp 01/2016)

Date Ranges: May 2015, September 2015, November 2015, January 2016

Product: Virbac Etiderm (Ethyl Lactate 10% w/w) Shampoo (16 oz)

Model:

NDC 051311-080-16

Lot Numbers:

130690 (Exp 05/2015)

131172 (Exp 09/2015)

131443 (Exp 11/2015)

140194 (Exp 01/2016)

Date Ranges: May 2015, September 2015, November 2015, January 2016

Product: Virbac Pyoben Gel (Benzoyl Peroxide 3% w/w) (1 oz)

Model:

NDC 051311-014-30

Lot Numbers:

130622 (Exp 05/2015)

Date Ranges: May 2015

Product: Virbac Pyoben Shampoo (Benzoyl Peroxide 3% w/w) (8 oz)

Model:

NDC 0151311-012-08

Lot Numbers:

131197 (Exp 10/2015)

140150 (Exp 01/2016)

Date Ranges: October 2015, January 2016

Product: Virbac Pyoben Shampoo (Benzoyl Peroxide 3% w/w) (16 oz)

Model:

NDC 051311-012-16

Lot Numbers:

131197 (Exp 10/2015)

140150 (Exp 01/2016)

Date Ranges: October 2015, January 2016

Product: Virbac Resiketochlor (Chlorhexidine Gluconate 2.3% w/w; ketoconazole 1% w/w) Leave-on Lotion (8 oz)

Model:

NDC 0151311-780-08

Lot Numbers:

130617 (Exp 05/2015)

130783 (Exp 06/2015)

131148 (Exp 09/2015)

131224 (Exp 10/2015)

140010 (Exp 12/2015)

140209 (Exp 02/2016)

140349 (Exp 03/2016)

140713 (Exp 06/2016)

140886 (Exp 07/2016)

141146 (Exp 09/2016)

Date Ranges: May 2015, June 2015, September 2015, October 2015, December 2015, February 2016, March 2016, June 2016, July 2016, September 2016

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71194

Status: Resolved

Manufacturer: Virbac AH, Inc

Sold By: Veterinarians; Pet specialty retailers

Manufactured In: United States

Units Affected: 4 products (17,352 /8 oz. bottles; 13,320 /16 oz. bottles; 6,840 /1 oz. bottles; 28,656 /8 oz.bottles; 19,980 /16 oz. bottles; 70,272 /8oz. bottles)

Distributed To: Nationwide