Swanson Ultra: Vitamin B12 Methylcobalamin High Absorption 60 serving per container…
Swanson Health Products, Inc recalled this product and the FDA reported the enforcement action on 23 March 2022 as Class II. The recall was initiated by the firm. Dietary supplement may contain potential metal shavings greater than or equal to 7mm in length.
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
- Swanson Ultra: Vitamin B12 Methylcobalamin High Absorption 60 serving per container, Item Code SWU122, UPC 87614-02122. Distributed by Swanson Health Products Fargo, ND 58104. 60 cc green PETE plastic bottle with black 33 induction seal cap
- UPC
- 8761402122
- Reason for recall
- Dietary supplement may contain potential metal shavings greater than or equal to 7mm in length.
- Recalling firm
- Swanson Health Products, Inc
- Firm location
- Fargo, North Dakota, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0867-2022
- Quantity
- 706 bottles
- Distribution
- Nationwide and Australia, Canada, and Malaysia
- Initiated
- 4 March 2022
- Reported by FDA
- 23 March 2022
- Terminated
- 9 December 2022
- Firm notified by
- Product codes
- Lot# 249012, EXP 02/24
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 9 months, from 4 March 2022 to termination on 9 December 2022. 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 FDA published the enforcement report 3 weeks after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
What this recall was for
Foreign material
A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.
A preventive controls plan covers foreign material 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 117.40
- Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
- 21 CFR 117.80(c)
- Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
- 21 CFR 117.150
- Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
Filed under dietary supplements. A product can sit in more than one.
Other dietary supplements 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 Swanson Health Products, Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2018-10-03 | Swanson Ultra, Himalayan Crystal Salt, #SWU403, Net Wt. 35.27 oz. (2.2 lbs) (1,000 grams). Product of Pakistan. Distributed by Swanson Health Products, Fargo, ND 58104. | Swanson Health Products, Inc | Himalayan Crystal Salt may contain metal wire pieces. | Class II |
| 2014-09-24 | Swanson 100% Certified Organic, Carob Powder, Raw Chocolate Substitute, Net wt 1 lb (454 grams), in round 1000 cc High Density Poly-ethylene plastic containers, Product of Italy, Distributed by Swanson Health Products, PO Box 2803, Fargo ND 58108 USA, SWF115. | Swanson Health Products, Inc | Swanson Certified Organic Carob Powder, item number SWF115 is being recalled due to a potential risk of Salmonella contamination from a raw ingredient used in this product. | Class I |
| 2014-05-21 | Swanson Full Spectrum Cilantro (Coriander) Herbal Supplement, 60 capsules, 425 mg, SW1112. UPC 87614-11112 | Swanson Health Products, Inc | The contract manufacturer has notified Swanson Health Products that Swanson Full Spectrum Cilantro (Coriander) (SW1112) is subject to a recall due to a potential risk of salmonella contamination. | Class I |
| 2013-11-27 | Swanson, Premium Brand, Full Spectrum Black Cumin Seed (Nigella Sativa) Dietary Supplement capsules, 400 mg, SW1361, UPS 0 87614 11361 6. | Swanson Health Products, Inc | Swanson Health Products is recalling two lots of Swanson Premium Full Spectrum Black Cumin Seed (Nigella sativa) Dietary Supplement Capsules. The product was found to be mislabel. Bottles of Black Cumin Seed from these two lots numbers (199399 & 201359) have been found to contain White Cumin Seed (Cuminum cyminum). | Class III |
| 2012-11-28 | Swanson Organic, 100% Certified Organic Fennel Seed, Net Wt 6 oz (45 grams), SWF092, UPC 0 87614 24092 3. | Swanson Health Products, Inc | This is to inform you of a product recall involving 2 lots of Swanson Organic 100% Certified Organic Fennel Seed (SWF092). Some jars of fennel seeds have been found to contain small, red beetle-type insects. | Class III |
All 6 records for Swanson Health Products, Inc
All 2022 recalls · All FDA food recall data
21 CFR 117.40 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.