Browse Drug Recalls
1,788 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,788 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 1,788 FDA drug recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 1, 2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Bli... | Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. | Class II | Apotex Inc. |
| Feb 28, 2019 | Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30... | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ... | Class II | Camber Pharmaceuticals Inc |
| Feb 28, 2019 | Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-3... | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ... | Class II | Camber Pharmaceuticals Inc |
| Feb 28, 2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-co... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-coun... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90... | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ... | Class II | Camber Pharmaceuticals Inc |
| Feb 28, 2019 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 coun... | Failed Dissolution Specifications; 9-monthstability timepoint | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Feb 28, 2019 | LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) ... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 9... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-cou... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 26, 2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufacture... | Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due... | Class III | Lupin Pharmaceuticals Inc. |
| Feb 25, 2019 | Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx... | Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. | Class II | Macleods Pharma Usa Inc |
| Feb 25, 2019 | Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, ... | Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. | Class II | Macleods Pharma Usa Inc |
| Feb 25, 2019 | Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottle... | Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. | Class II | Macleods Pharma Usa Inc |
| Feb 22, 2019 | Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per pac... | Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutrami... | Class I | Golean Detox US |
| Feb 22, 2019 | Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manu... | Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individ... | Class II | Akorn, Inc. |
| Feb 22, 2019 | Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, M... | Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed du... | Class II | Ascend Laboratories LLC |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Profes... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compoundi... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Pro... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional C... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Profe... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, P... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Com... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Comp... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Profes... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professio... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional ... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Profess... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professiona... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6m... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Profes... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile inje... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 coun... | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... | Class II | Macleods Pharma Usa Inc |
| Feb 21, 2019 | HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml inj... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only... | Failed Dissolution Specifications | Class III | Lannett Company Inc. |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Profession... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compoundin... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Profe... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 21, 2019 | PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professio... | Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... | Class II | Health Solutions Pharmacy Center Inc dba Profes... |
| Feb 20, 2019 | Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Ag... | Cross Contamination: Presence of IPA in finished product. | Class II | Vi-Jon, Inc. |
| Feb 19, 2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05)... | Failed dissolution specifications | Class III | Amerigen Pharmaceuticals Inc. |
| Feb 19, 2019 | Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL... | Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead ... | Class II | Leiter's Enterprises, Inc. |
| Feb 19, 2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-31... | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specificati... | Class III | American Health Packaging |
| Feb 15, 2019 | Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only,... | Subpotent Drug. | Class II | Heritage Pharmaceuticals, Inc. |
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.