Ortiga mas Ajo Rey Reforzado con Omega 3 — Class I drug recall D-1296-2022
Terminated recall by Amazon.com, Inc., reported 2022-07-27, distributed nationwide. Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofe
| Recall number | D-1296-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amazon.com, Inc., Seattle, WA, United States |
| Recall initiated | 2022-05-26 |
| Classified | 2022-07-27 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2022-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 35,622 cartons |
| Reason classes | undeclared allergen, unapproved product |
| Lot numbers | 040 |
| Expiration dates | 2025-02-09 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1296-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.