Browse Drug Recalls

180 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 180 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 180 FDA drug recalls in MD.

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DateProductReasonClassFirm
Oct 8, 2021 Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured fo... Out of specification result observed in a dissolution test at the 9-month long term stability tim... Class II Lupin Pharmaceuticals Inc.
Sep 27, 2021 Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 S... Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of steril... Class II AMIVAS (US), LLC
Aug 20, 2021 Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: ... Subpotent Class III Jubilant Cadista Pharmaceuticals, Inc.
Apr 29, 2021 Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manu... Subpotent Drug Class II Lupin Pharmaceuticals Inc.
Apr 1, 2021 Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Ju... Failed Dissolution Specifications Class II Jubilant Cadista Pharmaceuticals, Inc.
Mar 26, 2021 Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixe... Superpotent Drug Class II Lupin Pharmaceuticals Inc.
Feb 19, 2021 Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx... Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosi... Class III Jubilant Cadista Pharmaceuticals, Inc.
Jan 21, 2021 Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume afte... Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impu... Class III Lupin Pharmaceuticals Inc.
Nov 6, 2020 clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Man... Failed Tablet/Capsule Specification Class II Jubilant Cadista Pharmaceuticals, Inc.
Oct 26, 2020 Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) bli... Subpotent Class III Jubilant Cadista Pharmaceuticals, Inc.
Sep 24, 2020 Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 ... Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine... Class III Leadiant Biosciences, Inc.
Jul 21, 2020 Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrou... Failed Impurities/Degradation Specifications: Out of specification result observed in related sub... Class II Lupin Pharmaceuticals Inc.
Jul 17, 2020 Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Lim... Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle o... Class II Lupin Pharmaceuticals Inc.
Jul 7, 2020 Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottle... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jul 7, 2020 Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jul 7, 2020 Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottle... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jul 7, 2020 Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottle... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jul 2, 2020 Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx o... Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples. Class II Lupin Pharmaceuticals Inc.
Jun 11, 2020 Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
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.
May 26, 2020 Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured b... Presence of Foreign Substance visually consistent with the silica granules present in the desicca... Class III Jubilant Cadista Pharmaceuticals, Inc.
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.
Apr 1, 2020 Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: L... Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopr... Class II Lupin Pharmaceuticals Inc.
Mar 11, 2020 Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx ... CGMP Deviations: Presence of dark brown discoloration on edges of tablets Class II Jubilant Cadista 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 19, 2020 Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, R... Failed Impurities/Degradation Specification; high out of specification results observed Class II Lupin Pharmaceuticals Inc.
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.
Dec 2, 2019 Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufact... Presence of Foreign Substance: Presence of a foreign object in a single tablet. Class II Jubilant Cadista 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.
Sep 4, 2019 Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count... CGMP Deviation: Presence of dark brown discoloration on edges of tablets. Class II Jubilant Cadista 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 9, 2019 Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into ... Failed dissolution specifications : failed results at the 3-month stability time point. Class I Jubilant Cadista 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 29, 2019 Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx... Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on ... Class II Jubilant Cadista 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 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.

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.