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Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 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 8 FDA drug recalls.

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DateProductReasonClassFirm
Nov 20, 2025 Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Op... Incorrect Product Formulation Class II Fagron Compounding Services
Aug 29, 2025 bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single... Lack of Assurance of Sterility Class II Fagron Compounding Services
Jan 31, 2025 fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single... Lack of Assurance of Sterility Class II Fagron Compounding Services
Aug 15, 2024 Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx o... Lack of Assurance of Sterility Class II Fagron Compounding Services
Nov 10, 2023 Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25... Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL ... Class III Fagron Compounding Services
Jun 29, 2018 Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 m... Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 ... Class I Fagron Compounding Services LLC dba Fagron Ster...
Jun 29, 2018 Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 m... Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 ... Class I Fagron Compounding Services LLC dba Fagron Ster...
Jun 19, 2017 Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only.... Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier Class II Fagron Compounding Services LLC dba Fagron Ster...

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.