Browse Drug Recalls
116 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 116 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 116 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 28, 2020 | Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: ... | Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle. | Class II | Lupin Pharmaceuticals Inc. |
| Apr 24, 2020 | Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per un... | Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine st... | Class III | The Harvard Drug Group |
| Apr 20, 2020 | Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: ... | Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 se... | Class II | Lupin Pharmaceuticals Inc. |
| Apr 15, 2020 | Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin... | Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. | Class II | Lupin Pharmaceuticals Inc. |
| Mar 9, 2020 | Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and e... | Failed Content Uniformity Specifications: Out Of Specification test results observed for content ... | Class III | Lupin Pharmaceuticals Inc. |
| Mar 9, 2020 | Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.0... | Failed Content Uniformity Specifications: Out Of Specification test results observed for content ... | Class II | Lupin Pharmaceuticals Inc. |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dos... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 12, 2020 | Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, R... | Failed Dissolution Specifications: Low out of specification results observed in dissolution test ... | Class II | Lupin Pharmaceuticals Inc. |
| Jan 10, 2020 | Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.0... | CGMP Deviations: Out of specification test result observed during retrospective review of blend u... | Class III | Lupin Pharmaceuticals Inc. |
| Dec 26, 2019 | Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP a... | Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out ... | Class II | Lupin Pharmaceuticals Inc. |
| Dec 13, 2019 | Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx... | Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other i... | Class III | Lupin Pharmaceuticals Inc. |
| Dec 10, 2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-co... | Failed Dissolution Specifications: High out of specification result observed at stability studies. | Class III | Lupin Pharmaceuticals Inc. |
| Nov 1, 2019 | Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manuf... | Presence of Foreign substance: identified as a dead ant. | Class III | Lupin Pharmaceuticals Inc. |
| Nov 1, 2019 | Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (ND... | Presence of Foreign substance: identified as a dead ant. | Class III | Lupin Pharmaceuticals Inc. |
| Nov 1, 2019 | Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufact... | Presence of Foreign substance: identified as a dead ant. | Class III | Lupin Pharmaceuticals Inc. |
| Jul 19, 2019 | Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bott... | Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg ... | Class II | Lupin Pharmaceuticals Inc. |
| Jul 17, 2019 | Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tub... | Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of c... | Class III | Lupin Pharmaceuticals Inc. |
| Jul 17, 2019 | Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bot... | Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on... | Class II | Lupin Pharmaceuticals Inc. |
| Jul 11, 2019 | Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste... | Labeling: Missing label; Product complaints reported missing bottle label. | Class III | Lupin Pharmaceuticals Inc. |
| Jul 2, 2019 | Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025... | Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification resu... | Class II | Lupin Pharmaceuticals Inc. |
| May 23, 2019 | Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 m... | Complaint received of metal piece identified in the product bottle prior to the reconstitution. | Class II | Lupin Pharmaceuticals Inc. |
| Apr 1, 2019 | Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Man... | Failed Impurities/Degradation Specifications; 18 month long term stability study. | Class III | Lupin Pharmaceuticals Inc. |
| Mar 22, 2019 | Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg,... | Failed Impurities/Degradation Specifications: Out-of-specification results observed in related su... | Class II | Lupin Pharmaceuticals Inc. |
| Mar 13, 2019 | Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactur... | Defective Container: Repetitive complaints received indicating pump not working. | Class III | Lupin Pharmaceuticals 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 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 13, 2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and ... | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specificati... | Class III | Lupin Pharmaceuticals Inc. |
| Feb 1, 2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Man... | Failed Impurities/Degradation Specifications: Out of specification test results in related substa... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 28, 2019 | Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02)... | Failed Impurities/Degradation Specifications: OOS results observed in any other individual impuri... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 9, 2019 | Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lu... | CGMP Deviations; presence of extraneous material in the was observed in area that is between the... | Class II | Lupin Pharmaceuticals Inc. |
| Jan 7, 2019 | Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, ... | CGMP Deviation; manufacturing batch record could not be located | Class II | Lupin Pharmaceuticals Inc. |
| Jan 2, 2019 | Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-7... | CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to ... | Class II | Lupin Pharmaceuticals Inc. |
| Jan 2, 2019 | Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-7... | CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to ... | Class II | Lupin Pharmaceuticals Inc. |
| Dec 20, 2018 | Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 6818... | Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... | Class I | Lupin Pharmaceuticals Inc. |
| Dec 20, 2018 | Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 6... | Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... | Class I | Lupin Pharmaceuticals Inc. |
| Dec 20, 2018 | Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (ND... | Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... | Class I | Lupin Pharmaceuticals Inc. |
| Dec 20, 2018 | Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (ND... | Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... | Class I | Lupin Pharmaceuticals Inc. |
| Oct 9, 2018 | Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactur... | Defective Container: Repetitive complaints received indicating pump not working. | Class III | Lupin Pharmaceuticals Inc. |
| Jul 26, 2018 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactur... | Failed Impurities/Degradation Specifications: An out-of-specification result in the related subst... | Class III | Lupin Pharmaceuticals Inc. |
| May 17, 2018 | My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatmen... | Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulator... | Class II | Lupin Pharmaceuticals Inc. |
| Nov 21, 2017 | Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Ma... | Failed Dissolution Specification | Class III | Lupin Pharmaceuticals Inc. |
| Nov 17, 2017 | Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufacture... | Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy compla... | Class II | Lupin Limited |
| Jun 22, 2017 | Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, M... | Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 mon... | Class III | Lupin Pharmaceuticals Inc. |
| May 16, 2017 | Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewa... | Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last... | Class I | Lupin Limited (Unit 1) |
| May 2, 2017 | Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufa... | CGMP Deviations | Class III | Lupin Pharmaceuticals Inc. |
| Jun 1, 2016 | CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA,... | CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufactu... | Class III | Aidarex Pharmaceuticals LLC |
| Apr 6, 2016 | Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-51... | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... | Class III | Lupin 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.