Browse Drug Recalls
1,680 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,680 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 1,680 FDA drug recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 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 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 | 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 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 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 10, 2018 | Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 | Presence of Foreign Tablets/Capsules | Class III | Aidarex Pharmaceuticals 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 | 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 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 | 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 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), 150 mg ,a) 60 count (NDC ... | Failed Dissolution Specifications; during stability testing | Class III | InvaGen Pharmaceuticals, 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. |
| Mar 9, 2018 | Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), pa... | Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its lab... | Class III | Alva-Amco Pharmacal Companies., Inc. |
| Mar 9, 2018 | Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by:... | Failed Impurities/Degradation Specifications: High out of specification results for an impurity. | Class III | Akorn, Inc. |
| Mar 8, 2018 | Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr.... | Failed Stability Specifications:Out-of-specification results observed for viscosity during stabil... | Class III | Dr. Reddy's Laboratories, Inc. |
| Mar 5, 2018 | Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded ... | Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which con... | Class III | Pine Pharmaceuticals, LLC |
| Mar 5, 2018 | Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5... | Failed Impurities/Degradation Specifications | Class III | Novel Laboratories, Inc. |
| Mar 5, 2018 | Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd.... | Failed impurities/degradation specifications: Failure to water content and impurity | Class III | InvaGen Pharmaceuticals, Inc. |
| Mar 2, 2018 | Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flex... | Superpotent and Failed Stability Specifications; out of specification results for assay and water... | Class III | Renaissance Lakewood, LLC |
| Feb 28, 2018 | Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count... | Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to ... | Class III | Osmotica Pharmaceutical Corp |
| Feb 23, 2018 | Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured ... | Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polym... | Class III | AstraZeneca Pharmaceuticals LP |
| Feb 22, 2018 | labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Us... | Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indica... | Class III | SCA Pharmaceuticals, LLC. |
| Feb 21, 2018 | Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Onl... | Failed Stability Specification: OOS low viscosity results discovered during retain testing. | Class III | Akorn, Inc. |
| Feb 14, 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 |
| Feb 13, 2018 | Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufact... | Presence of Foreign Tablets/Capsules | Class III | Nostrum Laboratories Inc |
| Feb 7, 2018 | BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. ... | CGMP Deviations: not manufactured according to current good manufacturing practices. | Class III | Webrx dba RxPalace.com |
| Feb 5, 2018 | Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canad... | Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitt... | Class III | Genentech, Inc. |
| Feb 5, 2018 | Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Isra... | Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily reca... | Class III | Teva Pharmaceuticals USA |
| Feb 5, 2018 | Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, ... | Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a fa... | Class III | Sun Pharmaceutical Industries, Inc. |
| Feb 2, 2018 | Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, M... | Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg | Class III | Aurobindo Pharma Ltd. |
| Feb 2, 2018 | NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, ... | Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classificati... | Class III | ALLERGAN |
| Jan 29, 2018 | Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-... | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... | Class III | Teva Pharmaceuticals USA |
| Jan 29, 2018 | Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes o... | Subpotent Drug: Out of specification for assay (stability testing) | Class III | Mckesson Packaging Services |
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.