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Browse Drug Recalls

11 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 11 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 11 FDA drug recalls.

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DateProductReasonClassFirm
Apr 6, 2017 Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 6, 2017 Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opth... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 6, 2017 Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 6, 2017 Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose V... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 6, 2017 Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Mul... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 6, 2017 Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Onl... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Apr 6, 2017 Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Isomeric Pharmacy Solution, LLC
Mar 8, 2017 Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free... CGMP Deviations Class II Isomeric Pharmacy Solution, LLC
Aug 1, 2016 Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension,... Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate /... Class II Isomeric Pharmacy Solution, LLC
Jun 29, 2016 Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multi... Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action f... Class II Isomeric Pharmacy Solution, LLC
Feb 2, 2016 Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial... Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrec... Class III Isomeric Pharmacy Solution, 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.