Browse Drug Recalls
1,681 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,681 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 1,681 FDA drug recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 15, 2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC ... | Failed Dissolution Specifications; during stability testing | Class III | InvaGen Pharmaceuticals, Inc. |
| Mar 15, 2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles,... | Failed Dissolution Specifications; during stability testing | Class III | InvaGen Pharmaceuticals, Inc. |
| Mar 9, 2018 | Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), pa... | Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its lab... | Class III | Alva-Amco Pharmacal Companies., Inc. |
| Mar 9, 2018 | Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by:... | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Class III | Akorn, Inc. |
| Mar 8, 2018 | Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr.... | Failed Stability Specifications:Out-of-specification results observed for viscosity during stabil... | Class III | Dr. Reddy's Laboratories, Inc. |
| Mar 8, 2018 | E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Ma... | Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - met... | Class II | Bracco Diagnostics Inc. |
| Mar 8, 2018 | Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pa... | Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tada... | Class I | Jimmy Weber |
| Mar 7, 2018 | Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APO... | Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... | Class II | Apollo Care |
| 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 |
| Mar 7, 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 |
| 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 5, 2018 | Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johns... | Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morph... | Class II | Johnson Matthey Inc. |
| Mar 5, 2018 | Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded ... | Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which con... | Class III | Pine Pharmaceuticals, LLC |
| Mar 5, 2018 | Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5... | Failed Impurities/Degradation Specifications | Class III | Novel Laboratories, Inc. |
| Mar 5, 2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Sing... | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Class II | Sagent Pharmaceuticals Inc |
| Mar 5, 2018 | Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd.... | Failed impurities/degradation specifications: Failure to water content and impurity | Class III | InvaGen Pharmaceuticals, Inc. |
| Mar 5, 2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Sin... | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Class II | Sagent Pharmaceuticals Inc |
| Mar 5, 2018 | methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Sin... | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Class II | Sagent Pharmaceuticals Inc |
| Mar 2, 2018 | Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flex... | Superpotent and Failed Stability Specifications; out of specification results for assay and water... | Class III | Renaissance Lakewood, LLC |
| Feb 28, 2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count... | Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to ... | Class III | Osmotica Pharmaceutical Corp |
| Feb 26, 2018 | RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured ... | Failed Stability Specifications | Class II | Mckesson Packaging Services |
| Feb 26, 2018 | Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.... | Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in pr... | Class II | Paddock Laboratories, LLC. |
| Feb 23, 2018 | Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured ... | Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polym... | Class III | AstraZeneca Pharmaceuticals LP |
| Feb 23, 2018 | Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%... | Labeling: Label mix-up | Class II | Bayer HealthCare Pharmaceuticals, Inc. |
| Feb 22, 2018 | labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Us... | Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indica... | Class III | SCA Pharmaceuticals, LLC. |
| 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 | 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 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 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 | 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 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 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 |
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.