Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported December 25, 2013
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 554
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% Ophth…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Altaire Pharmaceuticals, Inc. recalled Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold unde… - a critical-severity action.
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold unde… was recalled by Altaire Pharmaceuticals, Inc. in December 25, 2013. Reason: Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the pre…. Check the official notice for the remedy. Verify recall #D-375-2014 with the FDA Drug before acting.
The recall
Altaire Pharmaceuticals, Inc. issued this critical-severity FDA Drug recall-Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the pre….
- Critical
- severity level
- Class I
- classification
- December 25, 2013
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-375-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-375-2014) was formally reported on December 25, 2013, with the manufacturer initiating the action on September 6, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Altaire Pharmaceuticals, Inc. is listed as the recalling firm, operating out of Aquebogue, NY. Federal records list the affected scope as 363,746 bottles..
The documented reason for this recall is: 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 thro… Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
363,746 bottles.
Related Recalls
6
5 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-375-2014 |
| Date reported | December 25, 2013 |
| Date initiated | September 6, 2013 |
| Recalling firm | Altaire Pharmaceuticals, Inc. |
| Firm location | Aquebogue, NY |
| Affected scope | 363,746 bottles. |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-375-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Altaire Pharmaceuticals, Inc.. Units affected: 363,746 bottles..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 25, 2013. Severity: Critical. Recall number: D-375-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-375-2014) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 25, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.