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Browse Drug Recalls

19 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 19 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 19 FDA drug recalls.

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DateProductReasonClassFirm
Oct 6, 2012 All Non Sterile Products manufactured by NECC (New England Compounding Center... GMP Deviations Class II New England Compounding Center
Oct 6, 2012 All Sterile Products manufactured by NECC (New England Compounding Center), F... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New E... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/m... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL a... Non-Sterility Class I New England Compounding Center
Sep 26, 2012 Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Comp... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL an... Non-Sterility Class I New England Compounding Center
Sep 26, 2012 Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufact... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Pho... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 ... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manu... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 m... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compo... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufact... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Comp... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL a... Non-Sterility Class I New England Compounding Center
Sep 26, 2012 Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Comp... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL an... Non-Sterility Class I New England Compounding Center

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.