Recall archive / FDA company announcement
Multiple brands: Lubricant Eye Drops & Multi-Symptom Eye Drops — FDA announcement Nov 15, 2023
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Nov 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Lubricant Eye Drops & Multi-Symptom Eye Drops
- Reason
- Device & Drug Safety Potential Safety Concerns
- Classification
- Not supplied
- Recalling firm
- Kilitch Healthcare India Limited
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 42d84b0951c7d6e0
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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.; 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| 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 |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Fda listing date
- Nov 15, 2023
- Company announcement date
- Nov 15, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.