Browse Drug Recalls
1,045 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,045 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 1,045 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Oct 4, 2021 | Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dro... | Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stabil... | Class II | Akorn, Inc. |
| Aug 23, 2021 | Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g... | Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ing... | Class II | Teligent Pharma, Inc. |
| Aug 2, 2021 | Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe... | Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stabil... | Class II | Akorn, Inc. |
| Jul 30, 2021 | Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg ... | Failed Stability Specifications; out of specification for shear. | Class II | Noven Pharmaceuticals Inc |
| Jul 30, 2021 | Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg ... | Failed Stability Specifications; out of specification for shear. | Class II | Noven Pharmaceuticals Inc |
| Jul 29, 2021 | GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with F... | Failed Stability Specification; Out of specification for Osmolarity | Class II | Novel Laboratories, Inc. d.b.a LUPIN |
| Jul 27, 2021 | MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 coun... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine,... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg An... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 c... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 co... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine,... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antih... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | allergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine ... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamin... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Wal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, pack... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | amazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 2... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistam... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihis... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihist... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packag... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | up&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihis... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antih... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine ... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 c... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, ... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihi... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine,... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihist... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihis... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihi... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 co... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antih... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, ... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 27, 2021 | GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 cou... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 2, 2021 | NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 cou... | Failed Dissolution Specification: Out of specification for dissolution during routine stability t... | Class II | The Harvard Drug Group |
| Jun 23, 2021 | LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vi... | FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramos... | Class III | Partner Therapeutics Inc |
| Jun 9, 2021 | Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For... | Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content we... | Class II | Genentech Inc |
| May 14, 2021 | Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-... | Presence of Foreign Substance: Foreign particles observed during routine stability testing. | Class II | Teligent Pharma, Inc. |
| Mar 29, 2021 | Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent... | Failed Stability Specifications: product did not meet viscosity results. | Class III | Teligent Pharma, Inc. |
| Mar 19, 2021 | Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only,... | Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown i... | Class II | Golden State Medical Supply Inc. |
| Mar 19, 2021 | Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, M... | Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological ... | Class II | X-Gen Pharmaceuticals Inc. |
| Mar 11, 2021 | Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only,... | Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown i... | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 8, 2021 | Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose... | Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed ... | Class II | Akorn, Inc. |
| Mar 4, 2021 | Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Phar... | Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities... | Class III | Teva Pharmaceuticals USA |
| Feb 26, 2021 | Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Di... | Failed Dissolution Specifications: Out-of-specification results observed for dissolution during s... | Class II | Dr. Reddy's Laboratories, 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. |
| Jan 7, 2021 | Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured ... | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t... | Class III | Bausch Health Companies, 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.