Altaire Pharmaceuticals, Inc.: Various Ophthalmic Ointments and Drops Recalled for Lack of Sterility

Agency Publication Date: November 16, 2019

Summary

Altaire Pharmaceuticals is recalling over 21.6 million units of various eye ointments and drops, including common brands like Perrigo, Walgreens, Equate, CVS Health, OCuSOFT, and Clear Eyes, due to a lack of assurance of sterility. Using products that are not sterile can cause serious eye infections, as these medications are applied directly to the eye's sensitive tissues. Affected products were distributed nationwide in the U.S. across major retailers like Walmart, CVS, and Walgreens, and consumers should immediately identify if their eye care products are part of this massive safety action.

Risk

A lack of sterility means the products may contain harmful bacteria or other microorganisms. Applying a contaminated product directly into the eye can lead to vision-threatening infections and other serious ocular complications.

What You Should Do

Check your medicine cabinet for various eye drops and ointments sold under brand names including Perrigo, Equate (Walmart), CVS Health, Walgreens, OCuSOFT, and Clear Eyes.
Verify the Lot Number and Expiration Date printed on the tube, bottle, or packaging against the extensive list of affected codes, which include Lot RGC (Exp 7/19), Lot SAC (Exp 1/20), Lot SEE (Exp 5/20), Lot 19095 (Exp 04/21), Lot 17196 (Exp 07/19), and Lot QJD (Exp 10/19) among many others.
Stop using any eye ointment or drops identified as part of this recall immediately to avoid the risk of infection.
Contact your healthcare provider or pharmacist for guidance if you have recently used these products and are experiencing eye pain, redness, or changes in vision.
Return any unused recalled product to the pharmacy or retail store where it was purchased for a full refund.
Contact Altaire Pharmaceuticals, Inc. at 1-888-723-3332 for additional information regarding this recall.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

Full Refund

Full refund upon return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy or retail place of purchase for a refund.

Affected Products

Product: Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment (3.5 gm)

Model:

NDC 0574-4160-35

Lot Numbers:

RGC (Exp 7/19)

RHB (Exp 8/19)

RHC (Exp 8/19)

RID (Exp 9/19)

RIC (Exp 9/19)

RIG (Exp 9/19)

RKH (Exp 11/19)

RKI (Exp 11/19)

RKJ (Exp 11/19)

RKK (Exp 11/19)

RKL (Exp 11/19)

RLM (Exp 12/19)

SAI (Exp 1/20)

SBG (Exp 2/20)

SBH (Exp 2/20)

SCF (Exp 3/20)

SEA (Exp 5/20)

SFA (Exp 6/20)

SFB (Exp 6/20)

SHA (Exp 8/20)

SIB (Exp 9/20)

SJC (Exp 10/20)

TAB (Exp 1/21)

TAF (Exp 1/21)

TBP (Exp 2/21)

TBQ (Exp 2/21)

TCV (Exp 3/21)

TCW (Exp 3/21)

Product: Perrigo Neo-Polycin Ophthalmic Ointment (3.5 g)

Model:

NDC 0574-4250-35

Lot Numbers:

SAC (Exp 1/20)

SLK (Exp 12/20)

Product: Perrigo Sterile Neo-Polycin HC Ophthalmic Ointment (3.5 g)

Model:

NDC 0574-4144-35

Lot Numbers:

SEE (Exp 5/20)

SEG (Exp 5/20)

SIE (Exp 9/20)

SKD (Exp 11/20)

Product: Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment (3.5 g)

Model:

NDC 0574-4021-35

Lot Numbers:

RGD (Exp 7/19)

RHL (Exp 8/19)

RHB (Exp 9/19)

RJF (Exp 10/19)

RJG (Exp 10/19)

SAJ (Exp 1/20)

SAK (Exp 1/20)

SAL (Exp 1/20)

SAM (Exp 1/20)

SBK (Exp 2/20)

SEH (Exp 5/20)

TCD (Exp 1/21)

Product: Perrigo Bacitracin Ophthalmic Ointment (3.5 g)

Model:

NDC 0574-4022-35

Lot Numbers:

RGA (Exp 7/19)

RGE (Exp 7/19)

RGG (Exp 7/19)

RGH (Exp 7/19)

RHM (Exp 8/19)

RJB (Exp 10/19)

RJA (Exp 10/19)

SCA (Exp 3/20)

SIC (Exp 9/20)

TAP (Exp 1/21)

TDE (Exp 4/21)

Product: Perrigo Sulfacetamide Sodium Ophthalmic Ointment (3.5 g)

Model:

NDC 0574-4190-35

Lot Numbers:

RJD (Exp 10/19)

SHG (Exp 8/20)

Product: Puralube Ointment Petrolatum Ophthalmic Ointment (1 g and 3.5 g)

Model:

NDC 0574-4025-11

NDC 0574-4025-35

Lot Numbers:

RJH (Exp 10/19)

SCC (Exp 3/21)

SGA (Exp 7/21)

SGH (Exp 7/21)

SHH (Exp 8/21)

SLL (Exp 12/21)

TAC (Exp 1/22)

Product: Walgreens Lubricant Eye Drops Moisturizing (15 mL)

Model:

Item #801483

Lot Numbers:

19095 (Exp 04/21)

Product: Walgreens Lubricant Eye Drops Moisturizing Twin Pack (2 x 15 mL)

Model:

Item #801477

NDC 0363-0185-49

Lot Numbers:

19095 (Exp 04/21)

Product: Walgreens Sodium Chloride Ophthalmic Ointment 5% (3.5 g)

Model:

NDC 0363-7500-50

Lot Numbers:

TCI (Exp 03/21)

Product: Walgreens Sodium Chloride Ophthalmic Solution 5% (15 mL)

Model:

NDC 0363-0193-13

Lot Numbers:

19105 (Exp 04/22)

19050 (Exp 02/22)

Product: Walgreens Lubricant Eye Ointment (3.5 g)

Model:

Item #801486

NDC 0363-0191-50

Lot Numbers:

TDB (Exp 4/22)

Product: Equate Restore Tears Lubricant Eye Drops Twin Pack (2 x 15 mL)

Model:

W-M item #552374320

NDC 49035-189-49

Lot Numbers:

17196 (Exp 07/19)

17292 (Exp 09/19)

17355 (Exp 11/19)

19040 (Exp 02/21)

Product: Equate Sterile Lubricant Stye Ointment (3.5 g)

Model:

NDC 49035-875-50

Lot Numbers:

SAJ (Exp 01/21)

SFE (Exp 06/21)

SIA (Exp 09/21)

RIE (Exp 09/20)

REH (Exp 05/20)

RAD (Exp 01/20)

TAH (Exp 01/22)

TDD (Exp 04/22)

Product: Equate Comfort Gel Lubricant Eye Gel Twin Pack (2 x 15 mL)

Model:

W-M item #552374319

NDC 49035-197-49

Lot Numbers:

17384 (Exp 12/19)

17259 (Exp 08/19)

19002 (Exp 01/21)

19041 (Exp 02/21)

18222 (Exp 09/20)

18084 (Exp 04/20)

Product: Equate Restore PM Nighttime Lubricant Eye Ointment (3.5 g)

Model:

W-M item #551282425

NDC 49035-191-50

Lot Numbers:

SKG (Exp 08/21)

SHK (Exp 08/21)

SHJ (Exp 08/21)

SEC (Exp 05/21)

SCB (Exp 03/21)

SBC (Exp 02/21)

RLB (Exp 12/20)

RBB (Exp 02/20)

RHR (Exp 08/20)

RFK (Exp 06/20)

RAB (Exp 01/20)

TAD (Exp 01/22)

TAQ (Exp 01/22)

TBI (Exp 02/22)

TDB (Exp 04/22)

QHE (Exp 08/19)

QJD (Exp 10/19)

SGE (Exp 07/21)

Product: CVS Health Natural Tears Lubricant Eye Drops (32 Single Use Vials)

Model:

Item #538397

Lot Numbers:

SEI (Exp 5/21)

SGC (Exp 7/21)

QGB (Exp 07/19)

QID (Exp 09/19)

RJC (Exp 10/20)

RCJ (Exp 03/20)

RCB (Exp 03/20)

TCJ (Exp 03/22)

Product: CVS Health Lubricant Eye Drops Mild to Moderate Dry Eye (15 mL)

Model:

Item #317916

Lot Numbers:

17196 (Exp 08/19)

17192 (Exp 09/19)

17355 (Exp 11/19)

18024 (Exp 01/20)

18036 (Exp 02/20)

18237 (Exp 09/20)

18293 (Exp 12/20)

18105 (Exp 04/20)

18179 (Exp 07/20)

19040 (Exp 2/21)

Product: Clear Eyes Redness Relief (15 mL)

UPC Codes:

678112254156

Lot Numbers:

QJD (Exp 10/19)

RFK (Exp 6/20)

SCB (Exp 3/21)

TBI (Exp 2/22)

Product: Ocusoft Tears Again Lubricant Eye Drops (15 mL)

Model:

NDC 54799-904-15

Lot Numbers:

16250 (Exp 09/19)

16268 (Exp 10/19)

16301 (Exp 11/19)

17088 (Exp 3/20)

17109 (Exp 4/20)

17318 (Exp 10/20)

17323 (Exp 10/20)

18014 (Exp 1/21)

18045 (Exp 2/21)

18059 (Exp 3/21)

18063 (Exp 3/21)

18117 (Exp 5/21)

18134 (Exp 5/21)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83265

Status: Resolved

Manufacturer: Altaire Pharmaceuticals, Inc.

Sold By: Walmart; CVS Pharmacy; Walgreens; Target

Manufactured In: United States

Units Affected: 117 products (1737549 containers; 121572 containers; 87922 containers; 261,528 units; 651528 units; 41148 units; 195,864 unts; 35,896 units; 30240 units; 43008 units; 45672 units; 557,376 units; 441792 units; 469128 units; 1537130 units; 55772 units; 259104 units; 99420 units; 50,904 units; 17,613 units; 152,369 units; 365,832 units; 100,680 units; 531,936 units; 101,712 units; 45,864 units; 114,504 units; 39,288 units; 101712 units; 45864 units; 39072 units; 284,232 units; 159,864 units; 238,968 units; 39,744 units; 77,760 units; 109,020 units; 48,168 units; 483528 units; 464424 units; 222096 units; 139572 units; 2,042,136 units; 159864 units; 39,744 units; 48,168 units; 58,704 units; 39,072 units; 66,159 units; 37656 units; 483,528 units; 464,424 units; 222,096 units; 24,024 units; 6,877 units; 306,479 units; 46345 units; 22494 units; 161077 units; 3060 units; 636 units; 390 units; 532,961 units; 48,542 units; 414,346 units; 809,600 units; 202266 units; 137 units; 2,392 units; 13,407 units; 24 units; 48,973 units; 13,375 units; 1,666 units; 4409 units; 12,716 units; 102,939 units; 88 units; 47 units; 48 units; 81403 units; 88,008 units; 75996 units; 9518 units; 103856 units; 14091 cartons.; 105609 units; 55,134 units; 296,314 units; 427,280 units; 81217 units; 29326 units; 19632 units; 13626 units; 50,304 units; 23974 units; 90,072 units; 90072 units; 73,548 units; 49527 units; 81969 units; 41925 units; 84216 units; 41906 units; 61830 units; 20666 units; 24144 units; 318,412 units; 1,381,638 units; 273,100 units; 195,864 units; 114504 units; 6024 units; 2870 units; 19632 units; 31070 units; 73548 units)

Distributed To: Nationwide

Agency Last Updated: January 27, 2020

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 · 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.

Summary

What You Should Do

Check your medicine cabinet for various eye drops and ointments sold under brand names including Perrigo, Equate (Walmart), CVS Health, Walgreens, OCuSOFT, and Clear Eyes.

Verify the Lot Number and Expiration Date printed on the tube, bottle, or packaging against the extensive list of affected codes, which include Lot RGC (Exp 7/19), Lot SAC (Exp 1/20), Lot SEE (Exp 5/20), Lot 19095 (Exp 04/21), Lot 17196 (Exp 07/19), and Lot QJD (Exp 10/19) among many others.

Stop using any eye ointment or drops identified as part of this recall immediately to avoid the risk of infection.

Contact your healthcare provider or pharmacist for guidance if you have recently used these products and are experiencing eye pain, redness, or changes in vision.

Return any unused recalled product to the pharmacy or retail store where it was purchased for a full refund.

Contact Altaire Pharmaceuticals, Inc. at 1-888-723-3332 for additional information regarding this recall.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Affected Products

Product: Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment (3.5 gm)

Model:

NDC 0574-4160-35

Lot Numbers:

RGC (Exp 7/19)

RHB (Exp 8/19)

RHC (Exp 8/19)

RID (Exp 9/19)

RIC (Exp 9/19)

RIG (Exp 9/19)

RKH (Exp 11/19)

RKI (Exp 11/19)

RKJ (Exp 11/19)

RKK (Exp 11/19)

RKL (Exp 11/19)

RLM (Exp 12/19)

SAI (Exp 1/20)

SBG (Exp 2/20)

SBH (Exp 2/20)

SCF (Exp 3/20)

SEA (Exp 5/20)

SFA (Exp 6/20)

SFB (Exp 6/20)

SHA (Exp 8/20)

SIB (Exp 9/20)

SJC (Exp 10/20)

TAB (Exp 1/21)

TAF (Exp 1/21)

TBP (Exp 2/21)

TBQ (Exp 2/21)

TCV (Exp 3/21)

TCW (Exp 3/21)

Product: Perrigo Neo-Polycin Ophthalmic Ointment (3.5 g)

Model:

NDC 0574-4250-35

Lot Numbers:

SAC (Exp 1/20)

SLK (Exp 12/20)

Product: Perrigo Sterile Neo-Polycin HC Ophthalmic Ointment (3.5 g)

Model:

NDC 0574-4144-35

Lot Numbers:

SEE (Exp 5/20)

SEG (Exp 5/20)

SIE (Exp 9/20)

SKD (Exp 11/20)

Product: Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment (3.5 g)

Model:

NDC 0574-4021-35

Lot Numbers:

RGD (Exp 7/19)

RHL (Exp 8/19)

RHB (Exp 9/19)

RJF (Exp 10/19)

RJG (Exp 10/19)

SAJ (Exp 1/20)

SAK (Exp 1/20)

SAL (Exp 1/20)

SAM (Exp 1/20)

SBK (Exp 2/20)

SEH (Exp 5/20)

TCD (Exp 1/21)

Product: Perrigo Bacitracin Ophthalmic Ointment (3.5 g)

Model:

NDC 0574-4022-35

Lot Numbers:

RGA (Exp 7/19)

RGE (Exp 7/19)

RGG (Exp 7/19)

RGH (Exp 7/19)

RHM (Exp 8/19)

RJB (Exp 10/19)

RJA (Exp 10/19)

SCA (Exp 3/20)

SIC (Exp 9/20)

TAP (Exp 1/21)

TDE (Exp 4/21)

Product: Perrigo Sulfacetamide Sodium Ophthalmic Ointment (3.5 g)

Model:

NDC 0574-4190-35

Lot Numbers:

RJD (Exp 10/19)

SHG (Exp 8/20)

Product: Puralube Ointment Petrolatum Ophthalmic Ointment (1 g and 3.5 g)

Model:

NDC 0574-4025-11

NDC 0574-4025-35

Lot Numbers:

RJH (Exp 10/19)

SCC (Exp 3/21)

SGA (Exp 7/21)

SGH (Exp 7/21)

SHH (Exp 8/21)

SLL (Exp 12/21)

TAC (Exp 1/22)

Product: Walgreens Lubricant Eye Drops Moisturizing (15 mL)

Model:

Item #801483

Lot Numbers:

19095 (Exp 04/21)

Product: Walgreens Lubricant Eye Drops Moisturizing Twin Pack (2 x 15 mL)

Model:

Item #801477

NDC 0363-0185-49

Lot Numbers:

19095 (Exp 04/21)

Product: Walgreens Sodium Chloride Ophthalmic Ointment 5% (3.5 g)

Model:

NDC 0363-7500-50

Lot Numbers:

TCI (Exp 03/21)

Product: Walgreens Sodium Chloride Ophthalmic Solution 5% (15 mL)

Model:

NDC 0363-0193-13

Lot Numbers:

19105 (Exp 04/22)

19050 (Exp 02/22)

Product: Walgreens Lubricant Eye Ointment (3.5 g)

Model:

Item #801486

NDC 0363-0191-50

Lot Numbers:

TDB (Exp 4/22)

Product: Equate Restore Tears Lubricant Eye Drops Twin Pack (2 x 15 mL)

Model:

W-M item #552374320

NDC 49035-189-49

Lot Numbers:

17196 (Exp 07/19)

17292 (Exp 09/19)

17355 (Exp 11/19)

19040 (Exp 02/21)

Product: Equate Sterile Lubricant Stye Ointment (3.5 g)

Model:

NDC 49035-875-50

Lot Numbers:

SAJ (Exp 01/21)

SFE (Exp 06/21)

SIA (Exp 09/21)

RIE (Exp 09/20)

REH (Exp 05/20)

RAD (Exp 01/20)

TAH (Exp 01/22)

TDD (Exp 04/22)

Product: Equate Comfort Gel Lubricant Eye Gel Twin Pack (2 x 15 mL)

Model:

W-M item #552374319

NDC 49035-197-49

Lot Numbers:

17384 (Exp 12/19)

17259 (Exp 08/19)

19002 (Exp 01/21)

19041 (Exp 02/21)

18222 (Exp 09/20)

18084 (Exp 04/20)

Product: Equate Restore PM Nighttime Lubricant Eye Ointment (3.5 g)

Model:

W-M item #551282425

NDC 49035-191-50

Lot Numbers:

SKG (Exp 08/21)

SHK (Exp 08/21)

SHJ (Exp 08/21)

SEC (Exp 05/21)

SCB (Exp 03/21)

SBC (Exp 02/21)

RLB (Exp 12/20)

RBB (Exp 02/20)

RHR (Exp 08/20)

RFK (Exp 06/20)

RAB (Exp 01/20)

TAD (Exp 01/22)

TAQ (Exp 01/22)

TBI (Exp 02/22)

TDB (Exp 04/22)

QHE (Exp 08/19)

QJD (Exp 10/19)

SGE (Exp 07/21)

Product: CVS Health Natural Tears Lubricant Eye Drops (32 Single Use Vials)

Model:

Item #538397

Lot Numbers:

SEI (Exp 5/21)

SGC (Exp 7/21)

QGB (Exp 07/19)

QID (Exp 09/19)

RJC (Exp 10/20)

RCJ (Exp 03/20)

RCB (Exp 03/20)

TCJ (Exp 03/22)

Product: CVS Health Lubricant Eye Drops Mild to Moderate Dry Eye (15 mL)

Model:

Item #317916

Lot Numbers:

17196 (Exp 08/19)

17192 (Exp 09/19)

17355 (Exp 11/19)

18024 (Exp 01/20)

18036 (Exp 02/20)

18237 (Exp 09/20)

18293 (Exp 12/20)

18105 (Exp 04/20)

18179 (Exp 07/20)

19040 (Exp 2/21)

Product: Clear Eyes Redness Relief (15 mL)

UPC Codes:

678112254156

Lot Numbers:

QJD (Exp 10/19)

RFK (Exp 6/20)

SCB (Exp 3/21)

TBI (Exp 2/22)

Product: Ocusoft Tears Again Lubricant Eye Drops (15 mL)

Model:

NDC 54799-904-15

Lot Numbers:

16250 (Exp 09/19)

16268 (Exp 10/19)

16301 (Exp 11/19)

17088 (Exp 3/20)

17109 (Exp 4/20)

17318 (Exp 10/20)

17323 (Exp 10/20)

18014 (Exp 1/21)

18045 (Exp 2/21)

18059 (Exp 3/21)

18063 (Exp 3/21)

18117 (Exp 5/21)

18134 (Exp 5/21)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83265

Status: Resolved

Manufacturer: Altaire Pharmaceuticals, Inc.

Sold By: Walmart; CVS Pharmacy; Walgreens; Target

Manufactured In: United States

Distributed To: Nationwide

Agency Last Updated: January 27, 2020