Altaire Recalls OCuSOFT retaine NaCl Ophthalmic Ointment Due to Sterility Concerns
Altaire Pharmaceuticals is recalling 19,632 units of OCuSOFT retaine NaCl Ophthalmic Ointment because the agency cannot assure the product's sterility.
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 source text explicitly states the agency classification is Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe) and cannot be lower, regardless of whether specific injuries are reported in the text.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling 19,632 units of OCuSOFT retaine NaCl Ophthalmic Ointment, 3.5g, SKU # 777-3-76. The recall was initiated due to a lack of assurance of sterility. The affected product was distributed nationwide in the United States.
The specific lot numbers involved in this recall are SAP (manufactured 1/20, expiration 3/16/2018), SFI (manufactured 6/20, expiration 10/29/2018), and TCI (manufactured 3/21). The source text does not specify the full expiration date for the TCI lot or the specific distribution channels.
Consumers who have this product should stop using it and contact Altaire Pharmaceuticals or their healthcare provider for instructions on how to dispose of the product or obtain a replacement. 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
- OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-76
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Ointment
- Hazard
- Affected units
- 19,632
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