Browse Drug Recalls
1,020 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,020 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 1,020 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 15, 2022 | Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent... | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... | Class II | Teligent Pharma, Inc. |
| Mar 15, 2022 | Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 ... | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... | Class II | Teligent Pharma, Inc. |
| Mar 15, 2022 | Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufact... | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... | Class II | Teligent Pharma, Inc. |
| Mar 15, 2022 | Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 5... | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... | Class II | Teligent Pharma, Inc. |
| Mar 15, 2022 | Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565... | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... | Class II | Teligent Pharma, Inc. |
| Mar 15, 2022 | Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, T... | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing ... | Class II | Teligent Pharma, Inc. |
| Feb 25, 2022 | Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, R... | Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipro... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Feb 24, 2022 | hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister pa... | Failed Impurities/Degradation Specifications: Out of specification result obtained during routine... | Class II | The Harvard Drug Group |
| Jan 19, 2022 | Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Labo... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 19, 2022 | Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's ... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 19, 2022 | Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 7, 2022 | Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by... | Failed Stability Specifications | Class II | VistaPharm, Inc. |
| Jan 5, 2022 | Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous an... | Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. | Class II | Akorn, Inc. |
| Dec 29, 2021 | Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, ... | Out-of-specification impurity test result observed at 18-month long term stability time point. | Class III | Lupin Pharmaceuticals Inc. |
| Dec 22, 2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... | Failed Stability Specifications: Out-of-specification results observed in a water loss test that ... | Class III | Lupin Pharmaceuticals Inc. |
| Nov 29, 2021 | PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coate... | CGMP Deviations: failed stability results, inadequate laboratory investigations, | Class II | ULTRAtab Laboratories, Inc. |
| Oct 20, 2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... | Failed Stability Specifications: Out-of-specification results observed in a water loss test that ... | Class III | Lupin Pharmaceuticals Inc. |
| Oct 13, 2021 | PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 ... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) t... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| Oct 13, 2021 | Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 6... | Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... | Class III | Ultra Seal Corporation |
| 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 |
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.