Browse Drug Recalls
2,002 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,002 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 2,002 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 26, 2022 | FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, I... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per carton... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsul... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufact... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 ... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healt... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 26, 2022 | Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automati... | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... | Class II | CARDINAL HEALTHCARE |
| Jan 7, 2022 | Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packag... | Mislabeling | Class III | Teva Pharmaceuticals USA |
| Jan 7, 2022 | Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, package... | Mislabeling | Class III | Teva Pharmaceuticals USA |
| Jan 5, 2022 | Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pe... | Labeling: Missing Label: label missing from some Semglee prefilled pens. | Class I | Mylan Pharmaceuticals Inc |
| Dec 6, 2021 | Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottl... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottl... | Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... | Class I | Valisa MFG LLC |
| Dec 3, 2021 | CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodiu... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodiu... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodi... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bo... | Labeling: Missing Label | Class III | Akorn, Inc. |
| Dec 3, 2021 | CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx o... | Labeling: Missing Label | Class III | Akorn, Inc. |
| Dec 3, 2021 | CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neut... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Dec 3, 2021 | CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluor... | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Class III | Dental Alliance Holdings LLC |
| Nov 30, 2021 | Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methan... | Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... | Class I | Aroma Release Technologies Inc |
| Nov 29, 2021 | Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, ... | Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5... | Class II | Denver Solutions, LLC DBA Leiters Health |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE, STRONGER SWAGGER, Dry Spray, 48 Hour, (Aluminum Chl... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 19, 2021 | AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vi... | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... | Class I | American Screening LLC |
| Oct 27, 2021 | Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx... | Labelling: Incorrect Exp. Date | Class II | Teva Pharmaceuticals USA |
| 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 | 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 12, 2021 | Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60... | Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actua... | Class I | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Oct 5, 2021 | Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S... | Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it ... | Class III | A-S Medication Solutions LLC. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a)... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, lab... | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated... | Class II | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Sep 28, 2021 | Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC... | Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... | Class III | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Sep 28, 2021 | The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL O... | Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Men... | Class II | Revive Personal Products Company |
| Sep 28, 2021 | Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC:... | Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... | Class III | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Sep 22, 2021 | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 22, 2021 | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 22, 2021 | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 22, 2021 | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals USA |
| Sep 22, 2021 | AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) ... | Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol | Class II | Teva Pharmaceuticals 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.