Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

1,463 recalls · Class I, newest first

Class I · High risk

BRILINTA (ticagrelor)

Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.

Terminated Particulate / foreign matter AstraZeneca Pharmaceuticals, LP NDC 0186-0777-08 D-0958-2017
Class I · High risk

Mibelas 24 Fe

Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.

Terminated Stability / shelf life Lupin Limited (Unit 1) NDC 68180-911-11 D-1093-2017
Class I · High risk

GEC LX Laxoplex 60 capsules Dietary Supplement

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.

Terminated Chemical / undeclared Genetic Edge Compounds LLC D-1092-2017
Class I · High risk

Phenobarbital Tablets USP

Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets

Terminated Labeling / mix-up C. O. Truxton NDC 0463-6160-10 D-1111-2017
Class I · High risk

Cummor Natural Male Enhancement

Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin

Terminated Chemical / undeclared Organic Herbal Supply D-0962-2017
Class I · High risk

Hyland's Baby Nighttime Teething Tablets

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

Terminated Wrong potency / content Standard Homeopathic Company NDC 54973-3197-1 D-0864-2017
Class I · High risk

Hyland's Baby Teething Tablets

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

Terminated Wrong potency / content Standard Homeopathic Company NDC 54973-3127-3 D-0863-2017
Class I · High risk

MACA gold tablets

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0571-2018
Class I · High risk

LIEN CHAN FOR SEVEN DAYS capsules

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0570-2018
Class I · High risk

DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0569-2018
Class I · High risk

Power V8 Viagra tablets

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0568-2018
Class I · High risk

YANSHIJIAONANG capsules

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Terminated Chemical / undeclared A&H Focal Inc. D-0567-2018

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