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 |
|---|---|---|---|---|
| Feb 10, 2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL)... | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... | Class II | Teva Pharmaceuticals USA |
| Feb 10, 2021 | Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Te... | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... | Class II | Teva Pharmaceuticals USA |
| Feb 10, 2021 | Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only... | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... | Class II | Teva Pharmaceuticals USA |
| Feb 10, 2021 | MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), ... | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... | Class II | Teva Pharmaceuticals USA |
| Feb 5, 2021 | Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distribute... | Failed Impurity/Degradation Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 4, 2021 | Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: ... | Failed Dissolution Specifications | Class II | Wilshire Pharmaceuticals Inc |
| Feb 4, 2021 | Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wi... | Failed Dissolution Specifications | Class II | Wilshire Pharmaceuticals Inc |
| Feb 2, 2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 g... | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Class III | Teligent Pharma, Inc. |
| Feb 2, 2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 gr... | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Class III | Teligent Pharma, Inc. |
| Feb 2, 2021 | Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Aut... | Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 m... | Class I | Apotex Corp. |
| Feb 2, 2021 | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 gr... | Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. | Class III | Teligent Pharma, Inc. |
| Feb 2, 2021 | Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automati... | Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 12... | Class I | Apotex Corp. |
| Feb 1, 2021 | Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed... | Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled a... | Class II | Kimberly-Clark Corporation |
| Jan 29, 2021 | Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manuf... | Failed Dissolution Specifications | Class III | Akebia Therapeutics dba Keryx Biopharmaceutials... |
| Jan 28, 2021 | Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose V... | Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled fo... | Class III | Accord Healthcare, Inc. |
| Jan 27, 2021 | Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 636... | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolact... | Class I | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Jan 27, 2021 | Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dos... | Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain t... | Class I | Meitheal Pharmaceuticals Inc |
| Jan 27, 2021 | Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Ma... | Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolact... | Class II | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Jan 25, 2021 | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets pe... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Nostrum Laboratories Inc |
| Jan 22, 2021 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx O... | CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si... | Class II | Ascend Laboratories LLC |
| Jan 22, 2021 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx On... | CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si... | Class II | Ascend Laboratories LLC |
| Jan 21, 2021 | Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic o... | Superpotent Drug. Lidocaine higher concentration than listed | Class II | Stanley Specialty Pharmacy Compounding and Well... |
| 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 20, 2021 | Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Au... | Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a... | Class II | Aurobindo Pharma USA Inc. |
| Jan 15, 2021 | Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by C... | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ... | Class I | Calvin Scott & Company, Inc. |
| Jan 15, 2021 | Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distribute... | Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ... | Class III | Calvin Scott & Company, Inc. |
| Jan 11, 2021 | Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONL... | Incorrect Labeling: Incorrect lot number on secondary packaging | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 8, 2021 | Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmac... | CGMP deviations. | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Jan 7, 2021 | Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceansi... | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t... | Class III | Bausch Health Companies, Inc. |
| Jan 7, 2021 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per cart... | Failed Dissolution Specifications | Class II | American Health Packaging |
| 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. |
| Jan 6, 2021 | Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ F... | Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly place... | Class II | DLC Laboratories, Inc |
| Jan 4, 2021 | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets pe... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Nostrum Laboratories Inc |
| Jan 1, 2021 | Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit ... | cGMP deviations: The firm was notified of the manufacturer's expanded recall. | Class II | Precision Dose Inc. |
| Dec 30, 2020 | Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) S... | Labeling: Missing instructions for use insert | Class II | Allergan, PLC. |
| Dec 30, 2020 | Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vi... | Discoloration and failed pH specifications | Class II | AuroMedics Pharma LLC |
| Dec 28, 2020 | Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only... | cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia... | Class II | Sunstar Americas, Inc. |
| Dec 28, 2020 | Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI... | Defective container: Customer complaints for oral solution leaking from bottles. | Class II | Akorn, Inc. |
| Dec 23, 2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottl... | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... | Class II | Shane Erickson Inc |
| Dec 23, 2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Mad... | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... | Class II | Shane Erickson Inc |
| Dec 23, 2020 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, ... | Presence of Foreign Substance: Particulate matter was found in multiple lots of product. | Class III | Genus Lifesciences Inc. |
| Dec 23, 2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Ma... | CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... | Class II | Shane Erickson Inc |
| Dec 23, 2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ... | Presence of Particulate Matter - found in reserve sample vials at the firm. | Class I | Fresenius Kabi USA, LLC |
| Dec 22, 2020 | Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL ... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Edge Pharma, LLC |
| Dec 22, 2020 | NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactur... | Failed Moisture Limits | Class III | Strides Pharma Inc. |
| Dec 21, 2020 | Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose... | Lack of assurance of sterility: The results of sterility tests of seven batches of product were o... | Class II | Merck Sharp & Dohme |
| Dec 18, 2020 | Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, R... | Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide i... | Class III | KVK-Tech, Inc. |
| Dec 17, 2020 | Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL ... | Failed Impurity/Degradation Specifications | Class II | Ascend Laboratories LLC |
| Dec 17, 2020 | Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 m... | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... | Class III | SCA Pharmaceuticals |
| Dec 17, 2020 | PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, ... | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... | Class II | SCA Pharmaceuticals |
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.