Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 1, 2018 | Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% ... | Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... | Class III | Baxter Healthcare Corporation |
| Aug 1, 2018 | Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% D... | Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... | Class III | Baxter Healthcare Corporation |
| Jul 26, 2018 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactur... | Failed Impurities/Degradation Specifications: An out-of-specification result in the related subst... | Class III | Lupin Pharmaceuticals Inc. |
| Jul 26, 2018 | Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grape... | Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label | Class III | Right Value Drug Stores, Inc. |
| Jul 11, 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... | Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay. | Class III | Renaissance Lakewood, LLC |
| Jul 11, 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... | Failed Stability Specifications: lot out of specification for elevated water vapor. | Class III | Renaissance Lakewood, LLC |
| Jul 11, 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 20... | Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodiu... | Class III | Renaissance Lakewood, LLC |
| Jul 10, 2018 | Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dos... | Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or e... | Class III | Valeant Pharmaceuticals North America LLC |
| Jul 9, 2018 | Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bot... | Subpotent Drug | Class III | Mylan Pharmaceuticals Inc. |
| Jun 27, 2018 | Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Ph... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 27, 2018 | Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex ... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 27, 2018 | Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Ph... | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... | Class III | Aidarex Pharmaceuticals LLC |
| Jun 26, 2018 | Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per car... | Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... | Class III | MAJOR PHARMACEUTICALS |
| Jun 26, 2018 | Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per c... | Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... | Class III | MAJOR PHARMACEUTICALS |
| Jun 25, 2018 | Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 ca... | Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT d... | Class III | AMERICAN HEALTH PACKAGING |
| Jun 19, 2018 | Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDP... | Failed Impurities/Degradation Specifications | Class III | Wockhardt Limited |
| Jun 19, 2018 | Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE ... | Failed Impurities/Degradation Specifications | Class III | Wockhardt Limited |
| Jun 15, 2018 | Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distri... | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Class III | Validus Pharmaceuticals, Inc. |
| Jun 15, 2018 | Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ra... | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Class III | Validus Pharmaceuticals, Inc. |
| Jun 13, 2018 | Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Lax... | Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ... | Class III | LUPIN SOMERSET |
| Jun 12, 2018 | Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. ... | Failed Impurities/Degradation Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jun 12, 2018 | Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. ... | Failed Impurities/Degradation Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jun 12, 2018 | Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 551... | Failed Impurities/Degradation Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Jun 8, 2018 | ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualge... | Labeling: Incorrect or Missing Lot and/or Exp Date. | Class III | Qualgen, LLC |
| Jun 8, 2018 | TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Q... | Labeling: Incorrect or Missing Lot and/or Exp Date. | Class III | Qualgen, LLC |
| Jun 7, 2018 | Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 m... | Superpotent Drug: Composite assay results obtained during routine stability testing were slightly... | Class III | Mylan Pharmaceuticals Inc. |
| May 29, 2018 | Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Onl... | Resuspension problems: Out of specification for appearance and resuspendability. | Class III | Pharmaceutical Associates Inc |
| May 25, 2018 | Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant ... | Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a... | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| May 24, 2018 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-coun... | Labeling: Missing Label | Class III | LUPIN SOMERSET |
| May 4, 2018 | T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.... | Subpotent | Class III | Milbar Laboratories, Inc. |
| May 4, 2018 | Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatolog... | Subpotent | Class III | Milbar Laboratories, Inc. |
| Apr 30, 2018 | Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 pa... | Failed Stability Specifications | Class III | Teva Pharmaceuticals USA |
| Apr 26, 2018 | Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473... | Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to... | Class III | Sun Pharmaceutical Industries, Inc. |
| Apr 23, 2018 | Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx On... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Apr 23, 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx on... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Apr 23, 2018 | Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg,... | Failed Dissolution Specifications. High dissolution results were obtained during stability testing. | Class III | Mckesson Packaging Services |
| Apr 17, 2018 | Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-... | Failed Dissolution Specification: Low dissolution outside of specifications | Class III | Rhodes Pharmaceuticals, L.P. |
| Apr 13, 2018 | OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box ... | Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS... | Class III | Septodont Inc. |
| Apr 13, 2018 | Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed... | Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement o... | Class III | Boiron Inc. |
| Apr 10, 2018 | Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 | Presence of Foreign Tablets/Capsules | Class III | Aidarex Pharmaceuticals LLC |
| Apr 10, 2018 | Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 ... | cGMP deviations | Class III | Pharmedium Services, LLC |
| Apr 9, 2018 | Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manuf... | Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. | Class III | LEADIANT BIOSCIENCES, INC |
| Apr 6, 2018 | Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bott... | Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisino... | Class III | Sandoz Incorporated |
| Mar 29, 2018 | Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-72... | Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... | Class III | Akorn, Inc. |
| Mar 29, 2018 | 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Pa... | Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... | Class III | Akorn, Inc. |
| Mar 29, 2018 | 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Pa... | Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... | Class III | Akorn, Inc. |
| Mar 21, 2018 | Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne... | Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability... | Class III | Mayne Pharma Inc |
| Mar 19, 2018 | Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by:... | Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One... | Class III | Glenmark Pharmaceuticals Inc., USA |
| Mar 19, 2018 | Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Qual... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Lake Erie Medical & Surgical Supply Inc |
| Mar 15, 2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles,... | Failed Dissolution Specifications; during stability testing | Class III | InvaGen Pharmaceuticals, 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.