Browse Drug Recalls

151 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 151 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 151 FDA drug recalls.

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DateProductReasonClassFirm
Aug 16, 2013 Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic,... Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at ... Class II Hospira Inc.
Aug 14, 2013 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Unit... Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and c... Class II Hospira Inc.
Jul 12, 2013 0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira ... Presence of particulate matter: visible free floating and partially embedded particulate matter i... Class I Hospira Inc.
Jul 12, 2013 0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira ... Presence of particulate matter: visible free floating and partially embedded particulate matter i... Class I Hospira Inc.
Jun 27, 2013 Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial,... Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of a... Class II Hospira Inc.
Jun 6, 2013 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Cont... Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the... Class II Hospira Inc.
May 25, 2013 Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patie... Presence of Particulate Matter; single visible particulate was identified during a retain sample ... Class II Hospira Inc.
May 16, 2013 Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, ... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class II Hospira Inc.
May 2, 2013 Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Sin... Presence of Particulate Matter: visible particles were identified floating in the primary container. Class II Hospira Inc.
Apr 30, 2013 DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL ba... Lack of Assurance of Sterility: Confirmed report of leaking in the primary container. Class II Hospira Inc.
Apr 8, 2013 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patie... Presence of Particulate Matter: A single visible particulate was identified during a retain sampl... Class II Hospira Inc.
Mar 29, 2013 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hos... Presence of Particulate Matter: reports of small grey/brown particles found in the primary contai... Class I Hospira Inc.
Feb 26, 2013 Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Flip... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class II Hospira Inc.
Feb 26, 2013 QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, ... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class II Hospira Inc.
Feb 26, 2013 Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx on... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class II Hospira Inc.
Feb 26, 2013 Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, ... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class II Hospira Inc.
Feb 25, 2013 Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient inf... Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed ... Class II Hospira Inc.
Feb 18, 2013 0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., La... Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrec... Class II Hospira Inc.
Feb 15, 2013 METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira,... Lack of Assurance of Sterility: There is the potential for the solution to leak from the administ... Class II Hospira Inc.
Feb 12, 2013 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Onl... Lack of Assurance of Sterility: There is a potential for the solution to leak from the administra... Class II Hospira Inc.
Jan 25, 2013 Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container,... Non-Sterility: Confirmed customer complaint of product contaminated with mold. Class I Hospira Inc.
Jan 10, 2013 Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hosp... Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial Class II Hospira, Inc.
Jan 8, 2013 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 6... Lack of Assurance of Sterility: There is the potential for solution to leak from the administrati... Class II Hospira Inc.
Nov 15, 2012 Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusio... Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observ... Class II Hospira Inc.
Nov 8, 2012 Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Steri... Crystallization: Product is being recalled due to visible particulates identified during a retain... Class I Hospira Inc.
Nov 8, 2012 Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Steri... Crystallization: Product is being recalled due to visible particulates identified during a retain... Class I Hospira Inc.
Oct 25, 2012 Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., ... Presence of Particulates; may contain glass particles Class II Hospira Inc.
Oct 22, 2012 HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MA... Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of ... Class II Hospira Inc.
Oct 5, 2012 Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers... Non-Sterility: One confirmed customer report that product contained spore-like particulates, cons... Class I Hospira Inc.
Aug 31, 2012 0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hosp... Presence of Particulate Matter; product may contain fibrous material Class I Hospira Inc.
Aug 29, 2012 Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusio... Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample... Class II Hospira Inc.
Aug 28, 2012 Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 m... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial Class II Hospira Inc.
Aug 28, 2012 Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, ... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class II Hospira Inc.
Aug 15, 2012 HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject pr... Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfille... Class I Hospira Inc.
Aug 3, 2012 Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patien... Presence of Particulate Matter: A single visible particulate was observed and confirmed in a samp... Class II Hospira Inc.
Jul 2, 2012 Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) ... Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin AP... Class III Hospira Inc.
Jun 27, 2012 Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplas... The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, a... Class II Hospira Inc.
Jun 27, 2012 Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplas... The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, a... Class II Hospira Inc.
Jun 27, 2012 Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antin... The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, a... Class II Hospira Inc.
Jun 27, 2012 Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplasti... The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, a... Class II Hospira Inc.
May 12, 2012 HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject pr... Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be... Class I Hospira Inc.
May 4, 2012 1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, I... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, ... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (N... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... Class II Hospira Inc.
May 4, 2012 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake F... Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possibl... 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.