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Low RiskFDA Vet
Pets & Animals/Pet Medications

PM Resources, Inc. dba Virbac Animal Health, Inc.: RILEXINE Chewable Tablets Recalled for Labeling and Foil Seal Defects

Agency Publication Date: December 19, 2016
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Summary

Approximately 93,481 bottles of RILEXINE (cephalexin) Chewable Tablets for dogs are being voluntarily recalled due to multiple labeling defects and potential packaging issues. Affected bottles may have missing or double labels, or may be missing critical lot and expiration date information. Additionally, some bottles within these lots may have loose or incompletely sealed foil liners under the cap, which could compromise the integrity of the medication.

Risk

Missing or illegible labels can lead to incorrect dosing or the use of expired medication, while compromised foil seals may allow moisture or contaminants to enter the bottle, potentially reducing the drug's effectiveness or safety for the animal.

What You Should Do

  1. Check your medication bottle for the following product names: RILEXINE (cephalexin) Chewable Tablets in 150 mg, 300 mg, or 600 mg strengths.
  2. Verify the lot numbers and expiration dates on the side of the bottle. Affected 150 mg lots include C5484P11 (Exp 02/18), C5486P11 (Exp 04/18), and C5496P11 (Exp 05/18).
  3. Check 300 mg bottles for lot numbers C5473P31 (Exp 02/18), C5485P31 (Exp 02/18), C5487P31 (Exp 03/18), and C5497P31 (Exp 05/18).
  4. Check 600 mg bottles for 17 specific lots, including C5477P61 through C5483P61, C5488P61 through C5493P61, C5495P61, C5501P61, C5502P61, and C5506P61 with various expiration dates between 11/17 and 07/18.
  5. Inspect the foil seal under the cap; if it is loose, missing, or partially attached, do not administer the tablets to your pet.
  6. Contact your veterinarian or pharmacist immediately to discuss whether your pet's medication is affected and to obtain a replacement.
  7. Return any unused or defective product to the pharmacy or place of purchase for a refund and contact the manufacturer, PM Resources, Inc. (Virbac), for further instructions.
  8. For additional questions, contact the FDA Center for Veterinary Medicine (CVM) at 240-402-7002.

Your Remedy Options

💰Full Refund

Drug recall return policy

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

Affected Products

Product: RILEXINE (cephalexin) Chewable Tablets 150 mg (100 Tablets)
Model:
NDC 051311-026-10
NADA # 141-326
Recall #: V-0038-2017
Lot Numbers:
C5484P11 (Exp 02/18)
C5486P11 (Exp 04/18)
C5496P11 (Exp 05/18)
Date Ranges: 02/18, 04/18, 05/18
Product: RILEXINE (cephalexin) Chewable Tablets 300 mg (100 Tablets)
Model:
NDC 051311-036-10
NADA # 141326
Recall #: V-0039-2017
Lot Numbers:
C5473P31 (Exp 02/18)
C5485P31 (Exp 02/18)
C5487P31 (Exp 03/18)
C5497P31 (Exp 05/18)
Date Ranges: 02/18, 03/18, 05/18
Product: RILEXINE (cephalexin) Chewable Tablets 600 mg (100 Tablets)
Model:
NDC 051311-046-10
NADA # 141-326
Recall #: V-0040-2017
Lot Numbers:
C5477P61 (Exp 11/17)
C5478P61 (Exp 11/17)
C5479P61 (Exp 12/17)
C5480P61 (Exp 01/18)
C5481P61 (Exp 01/18)
C5482P61 (Exp 01/18)
C5483P61 (Exp 01/18)
C5488P61 (Exp 02/18)
C5489P61 (Exp 03/18)
C5490P61 (Exp 03/18)
C5491P61 (Exp 03/18)
C5492P61 (Exp 03/18)
C5493P61 (Exp 04/18)
C5495P61 (Exp 04/18)
C5501P61 (Exp 05/18)
C5502P61 (Exp 06/18)
C5506P61 (Exp 07/18)
Date Ranges: 11/17, 12/17, 01/18, 02/18, 03/18, 04/18, 05/18, 06/18, 07/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75070
Status: Resolved
Manufacturer: PM Resources, Inc. dba Virbac Animal Health, Inc.
Sold By: veterinary clinics; pharmacies
Manufactured In: United States
Units Affected: 3 products (US: 28,968 bottles; US: 19,776 bottles; US: 44,737 bottles)
Distributed To: California, Florida, Georgia, Iowa, Indiana, Minnesota, Missouri, Oregon, Pennsylvania, Tennessee, Texas, Wisconsin, Puerto Rico

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