Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 9, 2020 | DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatolog... | GMP Deviations | Class II | Milbar Laboratories, Inc. |
| Oct 9, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... | Class III | ANI Pharmaceuticals, Inc. |
| Oct 9, 2020 | DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmeti... | GMP Deviations | Class II | Milbar Laboratories, Inc. |
| Oct 9, 2020 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... | Class III | ANI Pharmaceuticals, Inc. |
| Oct 9, 2020 | Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, D... | GMP Deviations | Class II | Milbar Laboratories, Inc. |
| Oct 8, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (ND... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Denton Pharma, Inc. |
| Oct 8, 2020 | Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottl... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Denton Pharma, Inc. |
| Oct 7, 2020 | Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 m... | Presence of particulate matter in solution - black and transparent particles | Class II | Baxter Healthcare Corporation |
| Oct 6, 2020 | metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: ... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | PD-Rx Pharmaceuticals, Inc. |
| Oct 6, 2020 | Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Sha... | DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking. | Class III | eVenus Pharmaceutical Laboratories |
| Oct 6, 2020 | metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Ok... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | PD-Rx Pharmaceuticals, Inc. |
| Oct 5, 2020 | BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx onl... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes ... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx... | An extraneous peak was observed for dissolution testing. | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in var... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syrin... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx... | An extraneous peak was observed for dissolution testing. | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in v... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx onl... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syrin... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx on... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in vari... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syring... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx... | An extraneous peak was observed for dissolution testing. | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Oct 5, 2020 | SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL sy... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 5, 2020 | FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL... | Non-Sterility | Class I | Med Shop Total Care Inc. |
| Oct 2, 2020 | Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0 | Discoloration. | Class II | Medichem S.A. |
| Oct 2, 2020 | Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, pac... | Out-of-specification organic impurity results obtained during routine stability testing. | Class III | Mylan Pharmaceuticals Inc. |
| Oct 2, 2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 ... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Marksans Pharma Limited |
| Oct 2, 2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Marksans Pharma Limited |
| Oct 1, 2020 | Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL),... | Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleadin... | Class I | ASHTEL STUDIOS, INC. |
| Sep 28, 2020 | Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-1... | Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity. | Class III | Teligent Pharma, Inc. |
| Sep 25, 2020 | Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Bould... | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. | Class I | Wishgarden Herbs, Incorporated |
| Sep 25, 2020 | Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulde... | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. | Class I | Wishgarden Herbs, Incorporated |
| Sep 25, 2020 | Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO... | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. | Class I | Wishgarden Herbs, Incorporated |
| Sep 25, 2020 | NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v... | Failed Impurties/Degradation Specifications: out of specification results for an impurity for one... | Class III | VistaPharm, Inc. |
| Sep 24, 2020 | SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL O... | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... | Class II | AA PRODUCTS 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. |
| Sep 24, 2020 | Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Man... | Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles. | Class III | Legacy Pharmaceutical Packaging LLC |
| Sep 23, 2020 | RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500... | CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Sep 17, 2020 | Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologic... | Labeling: Product Contains Undeclared API; Incorrect formulation | Class III | Grato Holdings, Inc. |
| Sep 17, 2020 | NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx On... | Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levot... | Class I | Acella Pharmaceuticals, LLC |
| Sep 17, 2020 | NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx O... | Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levot... | Class I | Acella Pharmaceuticals, LLC |
| Sep 17, 2020 | Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), L... | CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured ... | Class II | PD-Rx Pharmaceuticals, Inc. |
| Sep 16, 2020 | Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. In... | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Class II | Calvin Scott & Company, Inc. |
| Sep 16, 2020 | Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. In... | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Class II | Calvin Scott & Company, Inc. |
| Sep 16, 2020 | Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc.... | cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. | Class II | Calvin Scott & Company, Inc. |
| Sep 16, 2020 | Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhal... | Defective Delivery System: Sustained trend of failure to dispense complaints. | 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.