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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Refresh P.M. and Refresh LACRI-LUBE Eye Ointments Recalled for Sterility Risk

Agency Publication Date: September 23, 2024
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Summary

AbbVie Inc. is recalling 3,236,989 tubes of Refresh P.M. and Refresh LACRI-LUBE Lubricant Eye Ointments due to a potential breach in the tube seal. This defect means the sterility of the ointment cannot be guaranteed, as bacteria or other contaminants could enter the product. The recall affects 0.12 oz (3.5g) tubes distributed nationwide and to several foreign countries.

Risk

A breach in the tube seal compromises the product's sterility, which may lead to eye infections, irritation, or other ocular health complications if the contaminated ointment is used.

What You Should Do

  1. This recall affects Refresh P.M. Lubricant Eye Ointment (UPC 300230667043) and Refresh LACRI-LUBE Lubricant Eye Ointment (UPC 300230312042) in 0.12 oz (3.5g) tubes.
  2. Check your tube packaging for specific lot numbers and expiration dates ranging from September 2024 to May 2027. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact AbbVie Inc. for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Refresh P.M. Lubricant Eye Ointment (3.5g Tube)by Refresh
Variants: Mineral Oil 42.5%, White Petrolatum 57.3%
UPC Codes:
300230667043
Lot Numbers (64):
387392 (Exp. Feb 25)
387393 (Exp. Feb 25)
387394 (Exp. Feb 25)
387395 (Exp. Apr 25)
388729 (Exp. Apr 25)
388730 (Exp. Apr 25)
388731 (Exp. Apr 25)
388732 (Exp. Apr 25)
390391 (Exp. Apr 25)
390404 (Exp. Apr 25)
391688 (Exp. Oct 25)
391734 (Exp. Oct 25)
392616 (Exp. Dec 25)
392620 (Exp. Dec 25)
392987 (Exp. Jan 26)
393560 (Exp. Jan 26)
394816 (Exp. Nov 25)
394821 (Exp. Nov 25)
394927 (Exp. Feb 26)
394929 (Exp. Feb 26)
395713 (Exp. Mar 26)
395992 (Exp. Mar 26)
396815 (Exp. Mar 26)
396816 (Exp. Apr 26)
397248 (Exp. Apr 26)
397315 (Exp. Apr 26)
397316 (Exp. May 26)
397774 (Exp. May 26)
397775 (Exp. May 26)
397776 (Exp. May 26)
398436 (Exp. May 26)
398437 (Exp. May 26)
398621 (Exp. Jun 26)
398643 (Exp. Jun 26)
398739 (Exp. Jun 26)
398944 (Exp. Jun 26)
399001 (Exp. Jun 26)
399255 (Exp. Jun 26)
399270 (Exp. Jun 26)
399271 (Exp. Jun 26)
399798 (Exp. Jul 26)
399806 (Exp. Jul 26)
400003 (Exp. Jul 26)
408668 (Exp. Apr 27)
408723 (Exp. Apr 27)
408737 (Exp. Apr 27)
408853 (Exp. Apr 27)
408895 (Exp. Apr 27)
409121 (Exp. May 27)
409142 (Exp. May 27)

Distributed by Allergen, an AbbVie company.

Product: Refresh LACRI-LUBE Lubricant Eye Ointment (3.5g Tube)by Refresh
Variants: Mineral Oil 42.5%, White Petrolatum 57.3%
UPC Codes:
300230312042
Lot Numbers:
387489 (Exp. Oct 24)
387490 (Exp. Jun 25)
390422 (Exp. Nov 24)
390424 (Exp. Oct 24)
391692 (Exp. Jun 25)
391893 (Exp. Nov 25)
394822 (Exp. Feb 26)
395991 (Exp. Mar 26)
397905 (Exp May 26)
397973 (Exp May 26)
397974 (Exp May 26)
399019 (Exp. Jun 26)
399254 (Exp. Jun 26)
399922 (Exp. Jul 26)
408738 (Exp. Mar 27)
T3911 (Exp. Sep 24)
T4015 (Exp. Oct 24)
T4031 (Exp. Oct 24)
T4032 (Exp. Oct 24)
T4033 (Exp. Oct 24)
T4108 (Exp. Oct 24)

Distributed by Allergen, an AbbVie company.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95332
Status: Active
Manufacturer: AbbVie Inc.
Sold By: Retail Pharmacies; Drug Stores
Manufactured In: United States
Units Affected: 2 products (2,473,563 tubes; 763,426 tubes)
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 ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.