Browse Drug Recalls

26 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 26 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 26 FDA drug recalls.

Clear
DateProductReasonClassFirm
Apr 17, 2013 Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmac... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Comprehensive injection #4 - SS varied injectable Injectable Balanced Soluti... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a divisio... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmac... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compoun... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, ... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharm... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a di... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a d... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharma... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmac... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Ax... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Ph... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pha... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharma... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compou... Lack of Sterility Assurance Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Triamcinolone Diacetate Injectable Balanced Solutions, Compounding Pharmacy ... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a divisio... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compo... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compoundi... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy ... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...
Apr 17, 2013 Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a divisi... Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by th... Class II Axium Healthcare Pharmacy dba Balanced Solution...

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.