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Altaire Pharmaceuticals, Inc.
Altaire Pharmaceuticals, Inc.: 135 FDA recall reports
Every drug recall the FDA has published for Altaire Pharmaceuticals, Inc.. The fault, and how the agency graded it.
135Reports
1Class I
0Ongoing
2019-11-27Most recent
1 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: C
D-0394-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
- Where it went
- U.S.A. Nationwide
- How much
- N/A
CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881, Product Size: 2 x 10 mL,
D-0403-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
- Where it went
- U.S.A. Nationwide
- How much
- 39,744 units
Equate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 15 mL, Distributed by: Wal-Mart St
D-0369-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Equate Support Advanced Twin Pack W-M item #: 567371433, Package Size: 2 x 15 mL, Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-885-49
- Where it went
- U.S.A. Nationwide
- How much
- 259104 units
CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pha
D-0396-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
- Where it went
- U.S.A. Nationwide
- How much
- 222096 units
CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS
D-0375-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Item #247887
- Where it went
- U.S.A. Nationwide
- How much
- 100,680 units
CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Thera
D-0387-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Propylene Glycol 0.3%) Dry Eye Therapy, Sterile, 0.5 fl. oz. (15 mL), Item #895160, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
- Where it went
- U.S.A. Nationwide
- How much
- 238,968 units
CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item #881532, Distributed by
D-0384-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item #881532, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
- Where it went
- U.S.A. Nationwide
- How much
- 284,232 units
TRP Pink Eye Relief, 10 mL, NDC 17312-013-15
D-0471-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- TRP Pink Eye Relief, 10 mL, NDC 17312-013-15
- Where it went
- U.S.A. Nationwide
- How much
- 1,381,638 units
Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis
D-0356-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35
- Where it went
- U.S.A. Nationwide
- How much
- 651528 units
CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharma
D-0404-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
- Where it went
- U.S.A. Nationwide
- How much
- 48,168 units
TRP Blur Relief, 15 mL, NDC 17312-002-11
D-0469-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- TRP Blur Relief, 15 mL, NDC 17312-002-11
- Where it went
- U.S.A. Nationwide
- How much
- 24144 units
Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 1935
D-0458-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04
- Where it went
- U.S.A. Nationwide
- How much
- 90072 units
OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenb
D-0440-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05
- Where it went
- U.S.A. Nationwide
- How much
- 81403 units
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive
D-0379-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #994883, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39945 3
- Where it went
- U.S.A. Nationwide
- How much
- 114,504 units
iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry Eye Therapy
D-0430-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free Multi-Dose Mild Dry Eye Therapy, 0.25 FL OZ (7.5 mL), Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-52
- Where it went
- U.S.A. Nationwide
- How much
- 24 units
Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), Distributed by: Walmart Stor
D-0372-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-145-10 (Note: Support Harmony packaging was discontinued in January 2018.)
- Where it went
- U.S.A. Nationwide
- How much
- 17,613 units
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 5
D-0461-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05
- Where it went
- U.S.A. Nationwide
- How much
- 49527 units
CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CV
D-0376-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895
- Where it went
- U.S.A. Nationwide
- How much
- 531,936 units
iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ (10 mL), Mfd. By: Al
D-0435-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ (10 mL), Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-143-10
- Where it went
- U.S.A. Nationwide
- How much
- 12,716 units
ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50
D-0418-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50
- Where it went
- U.S.A. Nationwide
- How much
- 161077 units
Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g), Distributed by: Walmart
D-0367-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g), Distributed by: Walmart Stores Inc., Bentonville, AR 72716, W-M item #551282425, NDC 49035-191-50
- Where it went
- U.S.A. Nationwide
- How much
- 1537130 units
Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only,
D-0355-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only, Manufactured for Perrigo, Minneapolis, MN 55427, NDC 0574-4021-35
- Where it went
- U.S.A. Nationwide
- How much
- 261,528 units
Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7
D-0490-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7
- Where it went
- U.S.A. Nationwide
- How much
- N/A
Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15
D-0464-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15
- Where it went
- U.S.A. Nationwide
- How much
- 84216 units
Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye Lubricant, Net Wt. 0.125 oz.
D-0363-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye Lubricant, Net Wt. 0.125 oz. (3.5g), Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Item #801486, NDC 0363-0191-50
- Where it went
- U.S.A. Nationwide
- How much
- 45672 units
Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct., Mfd. By: b
D-0432-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct., Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-141-56
- Where it went
- U.S.A. Nationwide
- How much
- 13,375 units
Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15
D-0463-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15
- Where it went
- U.S.A. Nationwide
- How much
- 41925 units
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX
D-0446-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA, NDC 54799-505-05
- Where it went
- U.S.A. Nationwide
- How much
- 105609 units
Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL, Mfd. By: by Altaire Phar
D-0433-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-49
- Where it went
- U.S.A. Nationwide
- How much
- 1,666 units
Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire
D-0426-2020 · Class II · reported 2019-11-27 · Completed
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-182-13
- Where it went
- U.S.A. Nationwide
- How much
- 202266 units
Showing the 30 most recent of 135. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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