Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 21, 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... | Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmoti... | Class II | Renaissance Lakewood, LLC |
| Feb 21, 2018 | Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Onl... | Failed Stability Specification: OOS low viscosity results discovered during retain testing. | Class III | Akorn, Inc. |
| Feb 20, 2018 | Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multid... | Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and ... | Class II | Hospira Inc. A Pfizer Company |
| Feb 19, 2018 | Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufact... | cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | Kalchem International, Inc. |
| Feb 16, 2018 | 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PI... | Presence of Particulate Matter: Customer complaint of particulate matter which has been identifie... | Class II | B. Braun Medical Inc |
| Feb 15, 2018 | Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOL... | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... | Class II | Apollo Care |
| Feb 15, 2018 | PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodi... | Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. | Class II | Medline Industries Inc |
| Feb 15, 2018 | Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOc... | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... | Class II | Apollo Care |
| Feb 14, 2018 | SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 515... | Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paeci... | Class II | Fagron, Inc |
| Feb 14, 2018 | Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural ... | Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence... | Class I | Bella All Natural |
| Feb 14, 2018 | Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manuf... | Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride. | Class III | LEADIANT BIOSCIENCES, INC |
| Feb 13, 2018 | Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured... | Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were ex... | Class II | Hetero Labs Limited Unit V |
| Feb 13, 2018 | Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufact... | Presence of Foreign Tablets/Capsules | Class III | Nostrum Laboratories Inc |
| Feb 13, 2018 | Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for C... | Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were ex... | Class II | Hetero Labs Limited Unit V |
| Feb 9, 2018 | Nifedipine USP for prescription compounding, packaged in a) 5g (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 | Calcipotriene BP (Monohydrate) 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 | Testosterone Cypionate USP (Micronized) for prescription compounding, packag... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (N... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g ... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Estradiol 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 | Duloxetine 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 | Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (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 | Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, pa... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (ND... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Prilocaine 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 | Levetiracetam USP for prescription compounding, packaged in a) 500g (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 | Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Verapamil 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 | 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 |
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.