CLASS II ONGOING Drug recall · Reported 2 Oct 2024 · FDA Enforcement Report
Refresh P.M., (Mineral Oil recalled by AbbVie
AbbVie is recalling Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, distributed nationwide in the US. The recall was initiated on 16 Sep 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Timeline
| 16 Sep 2024 | Recall initiated by company | |
| 23 Sep 2024 | Classified by FDA | +7 days |
| 2 Oct 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
Where it was distributed
Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Which lots are affected?
Lot: 387392, 387393, 387394, Exp. Feb 25; 387395, 388729, 388730, 388731, 388732, 390391, 390404, Exp. Apr 25; 391688, 391734, Exp. Oct 25; 392616, 392620, Exp. Dec 25; 392987, 393560, Exp. Jan 26; 394816, 394821, Exp. Nov 25; 394927, 394929, Exp. Feb 26; 395713, 395992, 396815, Exp. Mar 26; 396816, 397248, 397315, Exp. Apr 26; 397316, 397774, 397775, 397776, 398436, 398437, Exp. May 26; 398621, 398643, 398739, 398944, 399001, 399255, 399270, 399271, Exp. Jun 26; 399798, 399806, 400003, Exp. Jul 26; 408668, 408723, 408737, 408853, 408895, Exp. Apr 27; 409121, 409142, Exp. May 27; 409261, Exp. Apr 27; T4534, T4535, T4591, T4592, Exp. Dec 24; T4660, T4661, T4696, T4697, T4709, T4772, T4773, Exp. Jan 25; T4844, T4845, Feb 25
Where was it sold?
Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95332| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Refresh Lacri-lube, (42.5% Mineral Oil recalled by AbbVie | AbbVie | Sterility | Nationwide |
More recalls from AbbVie
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pred Mild, prednisolone acetate ophthalmic suspension recalled by AbbViePred Mild | AbbVie | Potency & Assay | Nationwide |
| Drug | CLASS II | Refresh Lacri-lube, (42.5% Mineral Oil recalled by AbbVie | AbbVie | Sterility | Nationwide |
| Drug | CLASS III | Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg) recalledSynthroid | AbbVie | Other | IL |
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