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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 5 FDA drug recalls.

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DateProductReasonClassFirm
Oct 23, 2018 Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg,... Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser cont... Class II Janssen Pharmaceuticals, Inc.
Oct 23, 2018 Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28... Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser cont... Class II Janssen Pharmaceuticals, Inc.
Oct 19, 2016 Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-coun... Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be a... Class III Janssen Ortho L.L.C.
Apr 29, 2015 Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- c... Subpotent Drug Class II Janssen Pharmaceuticals, Inc.
Sep 11, 2013 Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only J... Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a steril... Class II Janssen Pharmaceuticals, Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.