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Browse Drug Recalls

186 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 186 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 186 FDA drug recalls.

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DateProductReasonClassFirm
Jul 26, 2017 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container... Presence of Particulate Matter; stainless steel Class II ICU Medical 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 15, 2017 Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4... Lack of Sterility Assurance Class II Hospira a Pfizer Company
May 18, 2017 Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx o... GMP Deviation; A foreign stopper was observed during packaging of a lot of product. Class II Hospira Inc., A Pfizer Company
Jan 24, 2017 Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package ... Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. Th... Class I Hospira Inc., A Pfizer Company
Nov 1, 2016 Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/m... Lack of Assurance of Sterility: Complaints of broken tips on the ampules. Class II Hospira Inc.
Sep 16, 2016 Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL... Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo... Class II Hospira Inc., A Pfizer Company
Sep 16, 2016 Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50... Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from fo... Class II Hospira Inc., A Pfizer Company
Aug 15, 2016 DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be ... Discoloration: Firm received complaints of product discoloration and particulates. Class II Hospira Inc.
Aug 4, 2016 Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Sing... Presence of particulate matter: Confirmed customer report for the presence of particulate matter ... Class I Hospira Inc., A Pfizer Company
Jun 29, 2016 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5... Failed Stability Specifications: The recalled lots did not meet the specification for color and p... Class III Hospira Inc.
Mar 23, 2016 Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, ... Failed pH Specifications: Confirmed high out of specification (OOS) results for pH. Class III Hospira Inc.
Mar 23, 2016 Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, ... Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter. Class I Hospira Inc.
Mar 15, 2016 Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL ... Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiratio... Class III Hospira Inc.
Mar 8, 2016 Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, In... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx on... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Ho... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hos... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hos... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Ho... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Feb 2, 2016 Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection ... Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect exp... Class III Hospira Inc.
Jan 5, 2016 Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g T... Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which ... Class I Hospira Inc.
Sep 29, 2015 Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL,... Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation p... Class III Hospira Inc.
Aug 25, 2015 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservati... Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded i... Class II Hospira, Inc.
Jul 2, 2015 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufact... Lack of assurance of sterility: Potential channel leaks near the threaded vial port. Class II Hospira Inc.
Jun 30, 2015 KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Via... Crystallization; identified as calcium salt of Ketorolac Class II Hospira Inc.
Jun 30, 2015 KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vi... Crystallization; identified as calcium salt of Ketorolac Class II Hospira Inc.
May 19, 2015 Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV... Failed pH Specifications: 12 month stability testing Class III Hospira Inc.
Apr 23, 2015 Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL... Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. Class I Hospira Inc.
Apr 23, 2015 KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside ... Crystallization Class II RemedyRepack Inc.
Mar 11, 2015 LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, M... Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the soluti... Class I Hospira Inc.
Mar 6, 2015 MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx onl... Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect ... Class I Hospira Inc.
Mar 5, 2015 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), U... Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative p... Class II Hospira Inc.
Mar 5, 2015 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospi... Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution. Class I Hospira Inc.
Feb 18, 2015 KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside... Crystallization Class II RemedyRepack Inc.
Jan 23, 2015 KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vi... Crystallization Class II Hospira Inc.
Jan 23, 2015 KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Via... Crystallization Class II Hospira Inc.
Dec 23, 2014 Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single pati... Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the n... Class II Hospira Inc.
Nov 7, 2014 Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g... Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another ... Class III Hospira Inc.
Oct 24, 2014 Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactur... Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thick... Class II Hospira Inc.
Oct 16, 2014 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Fr... Presence of particulate matter: A returned customer sample was evaluated and found to have human ... Class I Hospira Inc.
Oct 14, 2014 Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL contai... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, R... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only,... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx O... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospi... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira 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.