# FDA recall D-1296-2022

> **Amazon.com, Inc.** · Class I · drug recall initiated 2022-05-26.

## 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.

## Distribution

Nationwide within the U.S.A.

## Key facts

- **Recall number:** D-1296-2022
- **Recalling firm:** Amazon.com, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-05-26
- **Report date:** 2022-07-27
- **Termination date:** 2022-11-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Seattle, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1296-2022

## Citation

> AI Analytics. FDA recall D-1296-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-1296-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*