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Browse Drug Recalls

125 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 125 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 125 FDA drug recalls.

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DateProductReasonClassFirm
Feb 3, 2020 Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dos... Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects... Class II Pfizer Inc.
Nov 27, 2019 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only,... Labeling: Incorrect or Missing Lot and/or expiration date. Class II Pfizer Inc.
Oct 2, 2019 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 ... Lack of Assurance of Sterility: Bag has the potential to leak. Class II Pfizer Inc.
Sep 12, 2019 ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by... Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco... Class III Pfizer Inc.
Sep 12, 2019 Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made... Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco... Class III Pfizer Inc.
Sep 6, 2019 Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hosp... Lack of Assurance of Sterility Class II Pfizer Inc.
Aug 14, 2019 RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 ta... Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas. Class II Pfizer Inc.
Jul 9, 2019 Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 ... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Pfizer Inc.
Jul 9, 2019 Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Pfizer Inc.
Apr 29, 2019 Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per ... Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax... Class III Pfizer Inc.
Mar 15, 2019 Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 m... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Di... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Dist... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Di... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Mar 15, 2019 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL)... Presence of Particulate Matter; glass particulates Class I Pfizer Inc.
Mar 15, 2019 Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL... Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... Class III Pfizer Inc.
Dec 6, 2018 Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle... Superpotent Drug. Class II Pfizer Inc.
Oct 3, 2018 Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g T... Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Hep... Class II Pfizer Inc.
Sep 20, 2018 Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx ... CGMP Deviations; rejected product was used to manufacture final bulk lot Class II Pfizer Inc.
Sep 20, 2018 Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Steril... Lack of assurance of sterility: loss of container integrity. Class II Pfizer Inc.
Sep 19, 2018 Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, ... Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. Th... Class II Pfizer Inc.
Aug 28, 2018 Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx o... Failed Impurities/Degradation Specifications; Out of specification stability testing results at t... Class III Pfizer Inc.
Feb 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Feb 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Oct 20, 2017 diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 m... SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent Class I Pfizer Inc.
Oct 20, 2017 Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed ... SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent Class II Pfizer Inc.
Sep 1, 2017 Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactu... Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials. Class II Pfizer Inc.
Aug 30, 2017 Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only... Presence of Particulate Matter: glass particulate found in vial Class I Pfizer Inc.
Aug 22, 2017 Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL ... Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used... Class II Pfizer Inc.
Aug 22, 2017 HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in c... Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used... Class II Pfizer Inc.
Aug 4, 2017 Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 ... Failed Dissolution Specifications Class III Pfizer Inc.
Aug 4, 2017 Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750m... Failed Dissolution Specifications Class III Pfizer Inc.
Jul 12, 2017 Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL... CGMP Deviations: Firm failed to control impurity for color change at the API stage. Class III Pfizer Inc.
Jun 5, 2017 EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squ... Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eli... Class I Bristol-myers Squibb Company
Nov 22, 2016 PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantop... Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point. Class III Pfizer Inc.
Nov 7, 2016 LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, R... Superpotent Class II Pfizer Inc.
Sep 15, 2016 PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx o... Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expi... Class III Pfizer Inc.
Sep 9, 2016 Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For... Failed Impurities/Degradations Specifications; Out of specification results for two known degrada... Class III Pfizer Inc.
Apr 28, 2016 Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distribu... Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found. Class II Pfizer Inc.
Jan 11, 2016 Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by... FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due ... Class II Pfizer Inc.
Jan 11, 2016 Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by... FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due ... Class II Pfizer Inc.
Dec 2, 2015 Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, pac... Failed Dissolution Specification Class III Pfizer Inc.
Sep 24, 2015 Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed b... Subpotent Drug Class II Pfizer Inc.
Apr 23, 2015 Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 18, 2015 Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, pac... Presence of Particulate Matter Class I Mylan Institutional LLC
Feb 26, 2015 Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manuf... Failed Impurities/Degradation Specifications Class III Pfizer Inc.
Feb 26, 2015 Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufac... Failed Impurities/Degradation Specifications Class III Pfizer Inc.
Dec 3, 2014 Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61... Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cra... Class II Pfizer Inc.
Oct 10, 2014 TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL an... Crystallization: Impurities in a raw material used to manufacture the diluent can cause the forma... Class III Pfizer 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.