Altaire Recalls OCuSOFT Tetravisc Sterile Anesthetic Due to Sterility Concerns
Altaire Pharmaceuticals is recalling OCuSOFT Tetravisc Tetracaine HCl 0.5% sterile anesthetic because the company cannot guarantee the product is sterile.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves a sterile medical product where the lack of sterility assurance poses a significant risk of serious injury or infection.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, manufactured for OCuSOFT, Inc. The recall is being conducted because the company lacks assurance of the product's sterility.
The affected product is identified by NDC 54799-505-05. The recall covers 105,609 units distributed nationwide in the United States. Specific lot codes and expiration dates associated with the recall include 17232 (8/19), 17334 (11/19), 18249 (10/20), and 19125 (4/21).
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA, NDC 54799-505-05
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Anesthetic
- Hazard
- Affected units
- 105,609
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)
- 17232 8/19 17334 11/19 18249 10/20 19125 4/21
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 · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighKetorolac ophthalmic solution recalled over sterility assurance and bottle sealing concerns
FDA (Drugs) · 2025-10-08
- SevereKetorolac Tromethamine Ophthalmic Solution Recalled for Sterility Risk
FDA (Drugs) · 2025-07-02
- SevereTetracaine 0.5% Ophthalmic Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2014-03-12
- SevereAzelastine Hydrochloride Ophthalmic Solution Recalled Due to Sterility
FDA (Drugs) · 2025-07-02
- HighMethotrexate Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-02-02
- SevereOctreotide Acetate Injection 50 mcg/mL Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-08-25