Browse Drug Recalls
71 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 71 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 71 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 not support expirat... | Class II | American Pharmaceutical Ingredients LLC |
| Mar 7, 2018 | Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC... | Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expirat... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 2... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Itraconazole USP (Micronized) for prescription compounding, packaged in a) 1... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Progesterone USP (Micronized) (Yam) for prescription compounding, packaged i... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g ... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Fluticasone propionate USP (Micronized) for prescription compounding, package... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) ... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a)... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) ... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 100... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed ... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a)... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, p... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 50... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g ... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| 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 manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
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.