Lotsa Pasta International Food Shop Roasted Garlic Infused Olive Oil, Net Wt. 12 oz.
Hale inc recalled this product and the FDA reported the enforcement action on 10 December 2025 as Class II. The recall was initiated by the firm. Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Lotsa 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 case
- UPC
- 736211448415
- Reason for recall
- Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed.
- Recalling firm
- Hale inc
- Firm location
- Louisville, Kentucky, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- H-0240-2026
- Quantity
- 54 bottles (TOTAL)
- Distribution
- KY
- Initiated
- 9 September 2025
- Reported by FDA
- 10 December 2025
- Terminated
- 7 May 2026
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- No codes applied
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This is one of 2 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. All 2 of them are listed on this page.
- The recall ran for 8 months, from 9 September 2025 to termination on 7 May 2026. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The distribution pattern names 1 state, and the FDA published the enforcement report 3 months after the firm began the recall.
- Recalls of a grain, flour or pasta product run a median of 6 months, so this one was longer than usual for its category. Flour is a raw agricultural product that consumers treat as though it were cooked, which is the whole reason raw flour recalls exist: nothing in milling is a kill step, and the hazard only appears when somebody eats the dough.
What this recall was for
Clostridium botulinum
Clostridium botulinum recalls are recalls of the process, not of a test result: the organism produces its toxin without oxygen, so a low-acid food in a sealed container that missed its scheduled process is recalled whether or not toxin was ever found.
A preventive controls plan covers a botulism risk under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 113
- Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
- 21 CFR 108.35
- Emergency permit control: the registration and process filing a low-acid canned food processor must hold before it may operate.
Filed under grains, flour and pasta. A product can sit in more than one.
Every product in this recall
The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2025-12-10 | Lotsa 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 case | Hale inc | Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed. | Class II |
Other grains, flour and pasta recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Hale inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2025-12-10 | Lotsa 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 case | Hale inc | Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed. | Class II |
All 2025 recalls · All FDA food recall data
21 CFR 113 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.