Class III · Low risk
Proparacaine Hydrochloride Ophthalmic Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Affected NDC
24208-0730-06
Compare with the code on your package — it is the most precise check available.
Drug: Proparacaine Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Proparacaine Hydrochloride NDC 24208-0730 |
5 mg/mL | Solution/ Drops Ophthalmic |
Bausch & Lomb Incorporated | Rx |
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- NDC code
- 24208-730-06
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0661-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Proparacaine recalls
See all
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Class III · Low risk
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Class III · Low risk
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine -…
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Class II · Moderate risk
Proparacaine HCl Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by Mckesson Medical-Surgical Inc. Corporate Office
All 2024 recalls
Class II · Moderate risk
Infuvite Adult
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class II · Moderate risk
Medroxyprogesterone Acetate Injectable Suspension
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class II · Moderate risk
BENLYSTA (belimumab)
CGMP Deviations; potential temperature excursions due to transit delays
Class II · Moderate risk
Evenity
CGMP Deviations; potential temperature excursions due to transit delays
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