New England Compounding Center

Complete recall history across all FDA and CPSC categories — 19 total recalls

New England Compounding Center appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (19)

FDA drug safety enforcement actions by New England Compounding Center

Date Product Reason Class
Oct 6, 2012 All Non Sterile Products manufactured by NECC (New England Compounding Center... GMP Deviations Class II
Oct 6, 2012 All Sterile Products manufactured by NECC (New England Compounding Center), F... Lack of Assurance of Sterility Class II
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
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
Sep 26, 2012 Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL a... Non-Sterility Class I
Sep 26, 2012 Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center... Lack of Assurance of Sterility Class II
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
Sep 26, 2012 Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL an... Non-Sterility Class I
Sep 26, 2012 Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufact... Lack of Assurance of Sterility Class II
Sep 26, 2012 Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Pho... Lack of Assurance of Sterility Class II
Sep 26, 2012 Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 ... Lack of Assurance of Sterility Class II
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
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
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
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
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
Sep 26, 2012 Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL a... Non-Sterility Class I
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
Sep 26, 2012 Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL an... Non-Sterility Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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