Tetracaine Hydrochloride Ophthalmic Solution Recalled for Temperature Abuse
McKesson Medical-Surgical is recalling Tetracaine Hydrochloride Ophthalmic Solution due to cGMP deviations from temperature abuse. The recall affects 43 cartons distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a manufacturing quality issue (cGMP deviations related to temperature control) with no reported illnesses, injuries, or adverse events. The recall is precautionary in nature.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottles (NDC 0065-0741-14), manufactured by Alcon Surgical Inc. The recall affects 43 cartons of 12 blister packs that were distributed nationwide across the United States.
The recall is due to cGMP deviations involving temperature abuse. McKesson Medical-Surgical was unable to identify the particular lot numbers for each customer and has provided individual notification letters to affected customers listing the distribution dates and the dates the impacted product may have been shipped to them.
Healthcare providers and patients who received this product should verify whether their supply is affected based on the distribution dates provided in their notification letter. Patients should consult their healthcare provider regarding use of any recalled product.
The recalled product
- Product
- TETRACAINE HYDROCHLORIDE (TETRACAINE HYDROCHLORIDE)
- Brand
- TETRACAINE HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic Anesthetic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (1)
- 0300650741149
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 130 products in this recall →Related recalls
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · temperature abuse
See all →- SevereKayem Foods Recalls Ready-to-Eat Meat and Poultry Due to Temperature Abuse
USDA FSIS · 2026-10-17
- ModerateZoladex Goserelin Implant Recalled Due to Temperature Abuse
FDA (Drugs) · 2026-10-07
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
Similar recalls
- HighProparacaine Hydrochloride Eye Drops Recalled Due to Temperature Exposure
FDA (Drugs) · 2024-10-02
- ModerateMcKesson Recalls Hydralazine Hydrochloride Injection Due to Temperature Abuse
FDA (Drugs) · 2017-04-19
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- SevereAltaire Recalls Tetcaine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2019-11-27
- ModerateTetracaine HCl Nasal Solution Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-02-02
- ModerateMylan Amiodarone Hydrochloride Injection Recalled for Temperature Abuse
FDA (Drugs) · 2014-10-15