CLASS I Drug recall · Reported 25 Dec 2013 · FDA Enforcement Report

Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution recalled

Altaire Pharmaceuticals is recalling Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, sold under the following labels, distributed nationwide in the US. The recall was initiated on 6 Sep 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: 11440, Exp 09/13, labeled for CVS; 11441, Exp 09/13, labeled for CVS; 12042, Exp 01/14, labeled for CVS and Wal-Mart ; 12103, Exp 02/15, labeled for Wal-Mart; 12203, Exp 05/15, labeled for CVS and Wal-Mart; 12207, Exp 05/15, labeled for Wal-Mart; 12293, Exp 08/15, labeled for Wal-Mart; 12352, Exp 09/15, labeled for CVS and Target; and 12356, Exp 09/15, labeled for CVS and Target.

Quantity recalled363,746 bottles.

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

Recall number: D-375-2014
FDA event ID: 66217
Recalling firm: Altaire Pharmaceuticals, Aquebogue, NY
Classification: Class I
Status: Terminated
Recall initiated: 6 Sep 2013
FDA classified: 18 Dec 2013
Reported: 25 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Mold
Drug class: Eye Drops

Timeline

6 Sep 2013	Recall initiated by company
18 Dec 2013	Classified by FDA	+103 days
25 Dec 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.

Product as listed by the FDA

Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, Distributed by CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 053357 7 and UPC 0 50428 27364 7; (b) equate brand Lubricant Eye Drops, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 03420 3; and (c) up & up brand lubricant eye drops, Dist. by Target Corporation, Minneapolis, MN 55403, UPC 8 58961 79102 0.

Where it was distributed

Nationwide

Stores named: Walmart, Target, CVS

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #: 11440, Exp 09/13, labeled for CVS; 11441, Exp 09/13, labeled for CVS; 12042, Exp 01/14, labeled for CVS and Wal-Mart ; 12103, Exp 02/15, labeled for Wal-Mart; 12203, Exp 05/15, labeled for CVS and Wal-Mart; 12207, Exp 05/15, labeled for Wal-Mart; 12293, Exp 08/15, labeled for Wal-Mart; 12352, Exp 09/15, labeled for CVS and Target; and 12356, Exp 09/15, labeled for CVS and Target.

Where was it sold?

Nationwide

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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.

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Other Carboxymethylcellulose recalls

All 11

Reported	Class	Recall	Company	Reason	Where
14 May 2025Drug	CLASS II	Carboxymethylcellulose Sodium Ophthalmic Solution recalledCarboxymethylcellulose Sodium	BRS Analytical Services	Sterility	Nationwide
14 May 2025Drug	CLASS II	Carboxymethylcellulose Sodium Ophthalmic Gel recalled	BRS Analytical Services	Sterility	Nationwide
8 Jan 2025Drug	CLASS III	Carboxymethylcellulose Sodium Ophthalmic Solution recalled by AvKARECarboxymethylcellulose Sodium	AvKARE	Packaging Defects	Nationwide
14 Feb 2024Drug	CLASS I	Leader Dry Eye Relief (Carboxymethylcellulose Sodium 1%) recalledDry Eye Relief	Kilitch Healthcare India	Sterility	Nationwide
14 Feb 2024Drug	CLASS I	Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%) recalledLubricant Drops	Kilitch Healthcare India	Sterility	Nationwide