RecallRadar

FDA Drug recall D-1296-2022

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 (40…

On 2022-07-27 the FDA classified a Class I recall of 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 (40… by Amazon Com, citing marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1296-2022
ClassificationClass I
Statusterminated
Initiated2022-05-26
Published2022-07-27
Last updated2026-09-13 11:52 UTC
CompanyAmazon Com
DistributionUS

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

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.

Identifiers

upc3166557819586
code_infoLot #: 040 19, Exp. 09 FEB 2025

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1296-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.