Altaire Pharmaceuticals Recalls iSolutions Nano Tears Eye Drops for Sterility Concerns
Altaire Pharmaceuticals is recalling iSolutions Nano Tears MXP Forte eye drops due to a lack of assurance of sterility. The recall covers 48,973 units distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the 'lack of assurance of sterility' in an ophthalmic product represents a significant risk of serious infection, aligning with the Severe criteria for high-risk pathogens or significant injury potential.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free (NDC 59390-147-56). The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product consists of 0.6 mL x 32 ct vials. A total of 48,973 units were distributed nationwide in the United States. The recall notice lists the following codes: RGK 7/19, SDA 4/20, SFH 6/20, and TAN 1/21.
Consumers should stop using the recalled eye drops and contact their healthcare provider or the manufacturer for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- iSolutions Nano Tears MXP Forte 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 59390-147-56
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 48,973
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- RGK 7/19 SDA 4/20 SFH 6/20 TAN 1/21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 134 recalled by Altaire Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 134 products in this recall →Related recalls
Same manufacturer · Altaire Pharmaceuticals, Inc.
See all →- SevereCVS Health Dry Eye Relief Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2019-11-27
- SevereCVS Health Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2019-11-27
- SevereCVS Health Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2019-11-27
- SevereAltaire Recalls Equate Support Advanced Twin Pack Due to Sterility Concerns
FDA (Drugs) · 2019-11-27
- SevereAltaire Recalls OCuSOFT Ophthalmic Ointment Due to Sterility Concerns
FDA (Drugs) · 2019-11-27
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29