A number of eye drops and saline have been recalled due to unsanitary manufacturing conditions. Please review the product listings and links below. If you have these drops stop using them immediately.
January 31, 2024 – FDA warning regarding copycat redness relief drops: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-warns-consumers-over-copycats-bausch-lomb-eye-drops-2024-01-31/
January 2024: Addipak 5ml Lot: 3BO85 was recalled.
FOR IMMEDIATE RELEASE –November 13, 2023– Mumbai, Maharashtra, Kilitch Healthcare India Limited is voluntarily recalling the eye drops products listed in the table below to the consumer level with all lots within expiry with expiration dates ranging from November 2023 to September 2025 for all the below-mentioned products. These products are being recalled due to potential safety concerns after FDA investigators found insanitary conditions. Read the full release here: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kilitch-healthcare-india-limited-issues-voluntary-nationwide-recall-various-eye-drops-potential
| Product | Product Information | NDC NO | Retailer / Label |
|---|---|---|---|
| LUBRICATING TEARS EYE DROPS 15 ML | Dextran 70- 0.1% w/v, Glycerin 0.2% w/v, Hypromellose 0.3% w/v | 0536-1282-94 | Rugby |
| Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml | Polyvinyl alcohol Eye Drops 1.4% w/v | 0536-1325-94 | Rugby |
| High Performance Lubricant Eye Drops 15 ml (Single Pack) | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 11673-522-15 | Target |
| High Performance Lubricant Eye Drops 15 ml (Twin Pack) | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 11673-522-30 | Target |
| MULTI-ACTION RELIEF DROPS 15ML | Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops | 11822-2254-3 | Rite Aid |
| LUBRICATING GEL DROPS 10ML | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 11822-4540-3 | Rite Aid |
| LUBRICANT EYE DROPS 10ML (TWIN PACK) | Propylene glycol Eye Drops 0.6% w/v | 11822-4811-3 | Rite Aid |
| LUBRICANT GEL DROPS 15 ML | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 11822-9706-5 | Rite Aid |
| LUBRICANT EYE DROPS 15ML (TWIN PACK) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 11822-9707-5 | Rite Aid |
| Eye Irritation Relief 15 ml | Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops | 70000-0087-1 | Leader |
| Dry Eye Relief 10 ml | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 70000-0088-1 | Leader |
| Dry Eye Relief 15 ml | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 70000-0089-1 | Leader |
| Lubricant Eye Drops 15 ML (Single Pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 70000-0090-1 | Leader |
| Lubricant Eye Drops 15 ML (Twin Pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 70000-0090-2 | Leader |
| Lubricant Eye Drops 10 ml | Propylene glycol Eye Drops 0.6% w/v | 70000-0587-1 | Leader |
| LUBRICANT EYE DROP 10ML (TRIPLE PACK) | Propylene glycol Eye Drops 0.6% w/v | 76168-502-30 | Velocity |
| Lubricant Eye Drops 15 ML (Single Pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 76168-702-15 | CVS |
| Lubricant Eye Drops 15 ML (Twin Pack) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 76168-702-30 | CVS |
| Lubricant Gel Drops 15 ml (Single Pack) | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 76168-704-15 | CVS |
| Lubricant Gel Drops 15 ml (Twin Pack) | Carboxymethylcellulose Sodium Eye Drops 1.0% W/V | 76168-704-30 | CVS |
| Multi Action Relief Drops 15 ml | Polyvinyl alcohol 0.5% w/v, Povidone 0.6%w/v, Tetrahydrozoline 0.05% Eye Drops | 76168-706-15 | CVS |
| MILD MODERATE LUBRICATING EYE DROPS 15ML | Polyethylene glycol 400 0.4% w/v | 76168-711-15 | CVS |
| Lubricant Gel Drops 10 ml | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 76168-712-10 | CVS |
| Lubricant Eye Drops 10 ml (Single Pack) | Propylene glycol Eye Drops 0.6% w/v | 76168-714-10 | CVS |
| Lubricant Eye Drops 10 ml (Twin Pack) | Propylene glycol Eye Drops 0.6% w/v | 76168-714-20 | CVS |
| DRY EYE RELIEF 15 ML (TWIN PACK) | Carboxymethylcellulose Sodium Eye Drops 0.5% W/V | 76168-800-30 | Target |
| EQUATE HYDRATION PF LUBRICANT EYE DROPS 10ML | Polyethylene glycol 400 0.4%, Propylene glycol 0.3% Eye Drops | 79903-168-01 | Walmart |
FOR IMMEDIATE RELEASE – October 31, 2023 – Dublin, OH. Cardinal Health, Inc. is initiating a voluntary recall for all lots of ophthalmic products supplied by Velocity Pharma, LLC to the consumer level. Cardinal Health, Inc. received information from FDA indicating investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. The products are listed below, and you can read more and view product photos here: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-inc-issues-voluntary-nationwide-recall-certain-leadertm-brand-eye-drops-supplied
| Product Name | Package Description |
Brand Name |
NDC |
|---|---|---|---|
| Eye Irritation Relief (Polyvinyl Alcohol, 0.5%, Povidone, 0.6%, and Tetrahydrozoline Hydrochloride, 0.05%) |
0.5 FL OZ bottle (15 mL) |
LEADER™ | 70000-0087-1 |
| Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) |
0.5 FL OZ bottle (15 mL) |
LEADER™ | 70000-0089-1 |
| Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) |
0.5 FL OZ bottle (15 mL) |
LEADER™ | 70000-0090-1 |
| Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) |
2 bottles, 0.5 FL OZ (15 mL) each |
LEADER™ | 70000-0090-2 (Carton) 70000-0090-1 (Bottle) |
| Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%) |
0.33 FL OZ bottle (10 mL) |
LEADER™ | 70000-0088-1 |
| Lubricant Eye Drops (Propylene Glycol, 0.6%) |
0.33 FL OZ bottle (10 mL) |
LEADER™ | 70000-0587-1 |
FOR IMMEDIATE RELEASE – October 31, 2023 – La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntary recall for all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, LLC to the consumer level. The Harvard Drug Group, LLC received information from FDA indicating investigator found unsanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. The products are listed below, and you can read more and view product photos here: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-certain-rugbyr-laboratories-brand-eye
| Brand Name | Product Name | Package Description |
NDC |
|---|---|---|---|
| Rugby® | Polyvinyl Alcohol, 1.4% Lubricating Eye Drops |
0.5 oz bottle (15 mL) | 0536-1325-94 |
| Rugby® | Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) |
0.5 oz bottle (15 mL) | 0536-1282-94 |
August 25, 2023
FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination