Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 9, 2018 | Ketoconazole 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 | 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 5... | Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Tors... | Class II | Apace KY 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 5, 2018 | 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 25... | Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... | Class II | PharMEDium Services, LLC |
| Feb 5, 2018 | 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe,... | Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... | Class II | PharMEDium Services, LLC |
| Feb 5, 2018 | 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag... | Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... | Class II | PharMEDium Services, LLC |
| Jan 30, 2018 | VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, ... | Defective Container: Confirmed reports of loose vial crimps. | Class II | Millennium Pharmaceuticals Inc. |
| Jan 25, 2018 | PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC... | CGMP deviations. | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jan 22, 2018 | Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Mar... | Labeling: Label Error on Declared Strength | Class II | Astellas Pharma US Inc |
| Jan 19, 2018 | Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... | Class II | Flawless Beauty LLC |
| Jan 19, 2018 | TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials... | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... | Class II | Flawless Beauty LLC |
| Jan 19, 2018 | Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg g... | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... | Class II | Flawless Beauty LLC |
| Jan 19, 2018 | Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured i... | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... | Class II | Flawless Beauty LLC |
| Jan 19, 2018 | Ling Zhi capsules | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... | Class II | Flawless Beauty LLC |
| Jan 19, 2018 | TP Drug Laboratories Vitamin C ampules | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... | Class II | Flawless Beauty LLC |
| Jan 19, 2018 | Relumins Vitamin C Solvent ampules | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... | Class II | Flawless Beauty LLC |
| Jan 19, 2018 | Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettab... | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... | Class II | Flawless Beauty LLC |
| Jan 19, 2018 | Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg v... | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... | Class II | Flawless Beauty LLC |
| Jan 19, 2018 | Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... | Class II | Flawless Beauty LLC |
| Jan 19, 2018 | Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp... | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... | Class II | Flawless Beauty LLC |
| Jan 19, 2018 | Reiki Glutathione Whitening kits | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... | Class II | Flawless Beauty LLC |
| Jan 19, 2018 | Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [N... | CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... | Class II | AMERICAN HEALTH PACKAGING |
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.