Is this recall still active?

The FDA lists the recall as terminated (closed 07/31/2024). FDA has determined the recall is complete and closed it.

Checked Oct 26, 2026

Class IIDrug recallTerminated

Atropine sulfate 0.05% recall

Recalled by Pharmacy Innovations of Erie, PA · FDA report 02/01/2023

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class II; Moderate
Status: Terminated; Closed 07/31/2024
Recall started: 12/22/2022
Distribution: Nationwide

Reason for recall

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

Product: Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lot and code info: t20221025@32 t20221025@33
Recall number: D-0194-2023
Event ID: 91332
Initiated by: Voluntary: Firm initiated

Where it was distributed

Nationwide in the USA

Nationwide

Recall timeline

12/22/2022Firm started the recall
01/26/2023FDA classified it as Class II
02/01/2023Published in the FDA enforcement report
07/31/2024FDA closed (terminated) the recall

All products in this recall

59 products under event 91332

Frequently asked questions

Why was Atropine sulfate 0.05% recalled?: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
What does Class II mean?: Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Where was the recalled product sold?: Nationwide in the USA
Is this recall still active?: The FDA lists the recall as terminated (closed 07/31/2024). FDA has determined the recall is complete and closed it.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 02/01/2023 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class II
Status: Terminated
Type: Drug
Reported: 02/01/2023

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

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About this data

Recalls: Recall information comes from NHTSA, FDA, USDA, CPSC and other agencies. A product, vehicle or lot may be affected even if it is not listed here, and listings may be delayed. Check the official recall notice and contact the manufacturer or dealer to confirm whether your item is included.

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