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 |
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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