Browse Drug Recalls

114 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 114 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 114 FDA drug recalls.

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DateProductReasonClassFirm
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 Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (ND... Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... Class III Teva Pharmaceuticals USA
Dec 13, 2017 INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx ... Failed Stability Specifications: Product stability testing results did not meet specifications fo... Class II ALLERGAN
Nov 20, 2017 Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28... Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil a... Class II Teva Pharmaceuticals USA
Oct 25, 2017 Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-co... Failed dissolution specifications; all lots within expiry are being recalled due to out of specif... Class II Teva Pharmaceuticals USA
Sep 26, 2017 Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx ... Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity. Class II The Harvard Drug Group
Sep 5, 2017 Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Ph... Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is ... Class II Teva Pharmaceuticals USA
May 31, 2017 Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manuf... Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stab... Class I Teva Pharmaceuticals
Feb 28, 2017 Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicat... CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. Class III G & W Laboratories, Inc.
Feb 7, 2017 Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx... Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at... Class III Actavis Inc
Jan 30, 2017 Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufa... Failed Dissolution Specifications. Above out of specification for dissolution rate observed at th... Class II Actavis Inc
Jan 12, 2017 Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vial... Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. Class III Actavis Inc
Oct 13, 2016 AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Indi... Presence of Foreign Tablets/Capsules Class III Amerisource Health Services
Oct 6, 2016 NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and d... Presence of Foreign Tablets/Capsules Class III Actavis Elizabeth LLC
Aug 30, 2016 Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: A... Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration... Class III Actavis Laboratories, FL, Inc.
Aug 2, 2016 Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distribu... Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related comp... Class III Actavis Inc
Aug 2, 2016 Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 ... Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related comp... Class III Actavis Inc
Jul 11, 2016 Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles... Failed Dissolution Specifications Class II Actavis Inc
Jun 30, 2016 Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufact... Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specificati... Class II Actavis Inc
Mar 16, 2016 Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL... Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-sp... Class III Actavis Pharma Inc
Feb 16, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class II Actavis Elizabeth LLC
Feb 16, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class II Actavis Elizabeth LLC
Feb 16, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class II Actavis Elizabeth LLC
Feb 16, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class II Actavis Elizabeth LLC
Sep 25, 2015 Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint. Class II Actavis Laboratories, FL, Inc.
Jun 23, 2015 Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured... Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. Class III Actavis Laboratories, FL, Inc.
Jun 4, 2015 Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 ... Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth contro... Class III Actavis Inc
Apr 14, 2015 Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only. Distributed By: Actavis... Subpotent Drug: Flurandrenolide is subpotent. Class III Actavis Laboratories
Mar 26, 2015 Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, ... Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of ... Class III Actavis Laboratories, FL, Inc.
Feb 12, 2015 Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx... Subpotent Drug Class II Actavis Inc
Feb 12, 2015 Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx... Subpotent Drug Class II Actavis Inc
Feb 10, 2015 Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles,... Failed Dissolution Specifications Class II Actavis Elizabeth LLC
Dec 15, 2014 Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45... Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... Class II Actavis Elizabeth LLC
Dec 15, 2014 Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14... Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... Class II Actavis Elizabeth LLC
Dec 15, 2014 Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactu... Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and bre... Class II Actavis Elizabeth LLC
Sep 26, 2014 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Presence of split or broken tablets. Class II Actavis Laboratories, FL, Inc.
Aug 25, 2014 Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only... Subpotent Drug Class II Actavis Inc
Aug 25, 2014 Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only... Subpotent Drug Class II Actavis Inc
May 16, 2014 Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsul... Subpotent Drug. Class II Actavis Inc
Apr 24, 2014 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. Class II Actavis Laboratories, FL, Inc.
Apr 24, 2014 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. Class II Actavis Laboratories, FL, Inc.
Feb 10, 2014 Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured ... Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for... Class II Actavis Elizabeth LLC
Feb 7, 2014 Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use... Subpotent Drug: Drug potency was compromised during shipment. Class III Actavis
Feb 4, 2014 Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, ... Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. Class II Actavis Elizabeth LLC
Dec 20, 2013 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-c... Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. Class II Watson Laboratories, Inc.-(Actavis) - Florida
Dec 9, 2013 Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (ND... Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial... Class II Actavis Inc
Nov 15, 2013 BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 co... Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months. Class III Actavis Inc
Nov 6, 2013 Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth L... Subpotent Drug: During routine stability testing one tablet was found with tablet weight below sp... Class II Actavis Elizabeth LLC
Oct 9, 2013 Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Onl... Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below sp... Class II Actavis Elizabeth LLC
Aug 23, 2013 CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL ... CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was... Class II Central Shared Services dba Parallon

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.