Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported July 27, 2022
Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P. 33880, ASIN B084L2XM3Z, UPC 3166557819586
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Amazon.com, Inc. recalled Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 ta… - a critical-severity action.
Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 ta… was recalled by Amazon.com, Inc. in July 27, 2022. Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclof…. Check the official notice for the remedy. Verify recall #D-1296-2022 with the FDA Drug before acting.
The recall
Amazon.com, Inc. issued this critical-severity FDA Drug recall-Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclof….
- Critical
- severity level
- Class I
- classification
- July 27, 2022
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1296-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1296-2022) was formally reported on July 27, 2022, with the manufacturer initiating the action on May 26, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. Amazon.com, Inc. is listed as the recalling firm, operating out of Seattle, WA. Federal records list the affected scope as 35,622 cartons.
The documented reason for this recall is: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac. Distribution data in the federal record shows the product reached: Nationwide within the U.S.A.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
35,622 cartons
Related Recalls
6
0 from same agency
Product description
Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P. 33880, ASIN B084L2XM3Z, UPC 3166557819586
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-1296-2022 |
| Date reported | July 27, 2022 |
| Date initiated | May 26, 2022 |
| Recalling firm | Amazon.com, Inc. |
| Firm location | Seattle, WA |
| Affected scope | 35,622 cartons |
| Distribution | Nationwide within the U.S.A. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1296-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P. 33880, ASIN B084L2XM3Z, UPC 3166557819586. Recalled by Amazon.com, Inc.. Units affected: 35,622 cartons.
Why was this product recalled? ▼
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 27, 2022. Severity: Critical. Recall number: D-1296-2022.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the U.S.A..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1296-2022) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with AMASKY Nursing Pillows Recalled Due to Risk of Serious Inju… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 27, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.