Browse Drug Recalls

28 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 28 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 28 FDA drug recalls.

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DateProductReasonClassFirm
Jul 2, 2020 Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty A... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 26 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle,... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 3 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty A... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 12 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-0... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Yohimbine HCL 5.4mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Libe... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone 300 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Libert... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Sildenafil 50 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty A... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finast... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Tadalafil 7 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty A... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPha... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone (Modified Release) 150 mg Capsule, 90 capsules per bottle, Maste... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone Modified Release 100 mg Capsule, 90 capsules per bottle, MasterP... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Finasteride Plus 1.25mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 ... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone 50 mg Modified Release Capsule, 90 capsules per bottle, MasterPh... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle, MasterPharm... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone Modified Release 200 mg Capsule, 90 capsules per bottle, MasterP... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Estriol 6 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Libert... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richm... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jul 2, 2020 Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0... Lack of Processing Controls (lack of assurance of conformity to specifications). Class II MasterPharm LLC
Jun 9, 2020 Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle,... Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and b... Class I MasterPharm LLC
Apr 14, 2020 Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Com... Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain m... Class I MasterPharm LLC

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.