OCuSOFT Tears Again Lubricant Eye Drops Recalled for Sterility Concerns
Altaire Pharmaceuticals is recalling OCuSOFT Tears Again Lubricant Eye Drops due to a lack of assurance of sterility. The recall covers 81,217 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk conditions.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), NDC 54799-904-15. The recall is being conducted because of a lack of assurance of sterility in the product.
The recall involves 81,217 units of the eye drops. These products were distributed nationwide in the United States. The affected lots are identified by the following codes and dates: 17209 (7/21), 18168 (7/22), 18217 (8/22), 18260 (10/22), and 19094 (4/23).
Consumers should check their eye drops for these specific lot codes. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 81,217
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)
- 17209 7/21 18168 7/22 18217 8/22 18260 10/22 19094 4/23
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