Recall Register

Food, drugs, devices

Food recall: Lotsa Pasta International Food Shop Roasted Garlic Infused Olive Oil, Net Wt. 12 oz. (375ml), packaged in a glass bottle

FDA enforcement event 97901 · Class II · initiated 9 Sep 2025 · status Terminated · terminated 7 May 2026

FoodVoluntary: Firm initiated2 product recordsLouisville, KY

FDA enforcement event 97901 is a food recall by Hale inc of Louisville, KY, initiated 9 Sep 2025 and classified Class II, with 2 product records.

FDA defines Class II as 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. 54% of the 569 food enforcement events initiated in 2025 carry the same class.

Status: Terminated, terminated 7 May 2026. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Hale inc.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Hale inc, Louisville, KY.

Reason for recall

"Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed."

Distribution

"KY"

Product records

Recall numberProductQuantityClassStatusReport date
H-0240-2026Lotsa Pasta International Food Shop Roasted Garlic Infused Olive Oil, Net Wt. 12 oz. (375ml), packaged in a glass bottle, UPC 736211448415, packed 12 bottles per case54 bottles (TOTAL)Class IITerminated10 Dec 2025
H-0241-2026Lotsa Pasta International Food Shop Fresh Basil Infused Olive Oil, Net Wt. 12 oz. (375ml), packaged in a glass bottle, UPC 736211448316, packed 12 bottles per case54 bottles (TOTAL)Class IITerminated10 Dec 2025

Context

54%of 2025 food events are Class II569 events that year
2product records in this event
1event on this register for the firm

Questions and answers

Why was this food recalled?

FDA's record gives the reason for recall as: "Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "KY"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 7 May 2026. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA food enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.