American Pharmaceutical Ingredients LLC

Complete recall history across all FDA and CPSC categories, 71 total recalls

American Pharmaceutical Ingredients LLC 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 (71)

FDA drug safety enforcement actions by American Pharmaceutical Ingredients LLC. Showing most recent 50.

Date Product Reason Class
Mar 7, 2018 Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (... Stability Data Does Not Support Expiry: Stability data from manufacturer does... Class II
Mar 7, 2018 Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC... Stability Data Does Not Support Expiry: Stability data from manufacturer does... Class II
Feb 9, 2018 Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 2... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Itraconazole USP (Micronized) for prescription compounding, packaged in a) 1... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 585... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Progesterone USP (Micronized) (Yam) for prescription compounding, packaged i... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g (... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g ... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Fluticasone propionate USP (Micronized) for prescription compounding, package... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) ... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 5859... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-863... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-80... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-801... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a)... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 585... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (N... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) ... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 5859... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 585... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 100... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 5... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed ... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-85... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a)... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, p... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-803... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (ND... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 50... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g ... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II
Feb 9, 2018 Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (N... CGMP Deviations: Lack of stability data and controls to support the manufactu... Class II

View all 71 drug recalls →

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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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