Altaire Sterile Eye Wash Recalled for Lack of Sterility Assurance
Altaire Pharmaceuticals is recalling Altaire Sterile Eye Wash because the company cannot guarantee the product is sterile.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the provided text, the loss of sterility in an ophthalmic product is a significant safety hazard warranting a high severity rating under the Class II classification.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), NDC 59390-175-13. The recall was initiated because the company lacks assurance of the product's sterility.
The recall involves 48,542 units distributed nationwide in the United States. The affected lots include codes 17241, 17322, 18169, and 19052.
Consumers should stop using the product and contact Altaire Pharmaceuticals for further instructions or a refund.
The recalled product
- Product
- Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 48,542
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 · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15