Browse Drug Recalls
142 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 142 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 142 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 23, 2023 | Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Ma... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Oct 23, 2023 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30... | Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of... | Class III | Glenmark Pharmaceuticals Inc., USA |
| Oct 20, 2023 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-cou... | Failed Impurities/Degradation Specifications | Class III | Glenmark Pharmaceuticals Inc., USA |
| Oct 20, 2023 | Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Man... | Failed Dissolution Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 14, 2023 | Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 ... | Subpotent: Out of Specification for Assay Test at the 3-month time point. | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jul 11, 2022 | Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Us... | Defective Container: Tube split from side seam | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufacture... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, R... | Defective Container: Recall of these batches has been initiated due to complaints of difficult t... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx ... | Defective Container: Recall of these batches has been initiated due to complaints of difficult t... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bot... | Failed Tablet/Capsule Specification : Capsule breakage | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jun 16, 2022 | Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC ... | Defective Container | Class III | Glenmark Pharmaceuticals Inc., USA |
| May 13, 2022 | Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Dist... | CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. | Class II | Direct Rx |
| Apr 25, 2022 | Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462... | cGMP deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 25, 2022 | Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manuf... | cGMP deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 25, 2022 | Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manu... | cGMP deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Sep 14, 2021 | Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Di... | CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory. | Class II | Direct Rx |
| Aug 27, 2021 | Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation On... | Lack of Assurance of Sterility | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufa... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceutic... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manu... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmac... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufa... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactu... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Conta... | Lack of Assurance of Sterility | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 15, 2021 | Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Gl... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: G... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: G... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Gl... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: G... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: G... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Nov 15, 2019 | Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68... | Defective delivery system; product is not foaming or is coming out as liquid. | Class III | Glenmark Pharmaceuticals Inc., USA |
| Nov 15, 2019 | Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100... | Defective delivery system; product is not foaming or is coming out as liquid. | Class III | Glenmark Pharmaceuticals Inc., USA |
| Oct 22, 2019 | Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts... | Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 7, 2019 | Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tube... | Temperature Abuse: Complaints received of liquidy texture. | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jul 23, 2019 | Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-19... | GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 3, 2019 | Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (... | Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 25, 2019 | Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufacture... | Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 26, 2018 | Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC ... | Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator | Class II | Glenmark Pharmaceuticals Inc., USA |
| Nov 27, 2018 | Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufa... | Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule... | Class III | Glenmark Pharmaceuticals Inc., USA |
| Mar 19, 2018 | Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by:... | Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One... | Class III | Glenmark Pharmaceuticals Inc., USA |
| Nov 20, 2017 | Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: G... | CGMP Deviations: Market complaints related to "gritty texture". | Class II | Glenmark Pharmaceuticals Inc., USA |
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.