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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
Oct 14, 2014 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufacture... Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container... Class II Hospira Inc.
Oct 14, 2014 5% Dextrose and 0.9% 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 6, 2014 Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Flipto... Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class II Hospira Inc.
Oct 6, 2014 Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop ... Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class II Hospira Inc.
Oct 6, 2014 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patie... Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class I Hospira Inc.
Oct 1, 2014 Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a)... Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials th... Class II Hospira Inc.
Sep 9, 2014 Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuj... Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine... Class II Hospira Inc.
Sep 4, 2014 Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Fre... Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown,... Class II Hospira Inc.
Jul 29, 2014 Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Singl... Presence of Particulate Matter: The product was discolored and contained visible particulates (ir... Class I Hospira Inc.
Jul 10, 2014 LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers... Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of... Class I Hospira Inc.
Jun 27, 2014 Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), ... Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing. Class II Hospira Inc.
Jun 17, 2014 Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (15... Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible ... Class I Hospira Inc.
Jun 6, 2014 Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/25... Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container... Class II Hospira Inc.
May 16, 2014 Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multido... Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating i... Class II Hospira Inc.
Apr 21, 2014 Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (2... Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible ... Class I Hospira Inc.
Apr 18, 2014 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-do... Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, ... Class I Hospira Inc.
Apr 2, 2014 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administr... Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during ... Class I Hospira Inc.
Mar 27, 2014 Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Singl... Presence of Particulate; red and black particulate within the solution and embedded within the pl... Class II Hospira Inc.
Mar 25, 2014 Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, R... Labeling; Missing label; ampoules are missing the immediate container label Class III Hospira Inc.
Feb 11, 2014 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hosp... Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, ... Class II Hospira Inc.
Feb 10, 2014 Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free... Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the ... Class II Hospira Inc.
Dec 23, 2013 Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose... Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass co... Class I Hospira Inc.
Dec 12, 2013 Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patie... Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified ... Class II Hospira Inc.
Oct 18, 2013 Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-pre... Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in th... Class I Hospira Inc.
Oct 11, 2013 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patie... Presence of Particulate Matter: Visible particles embedded in the glass identified during a retai... Class II Hospira Inc.
Oct 11, 2013 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fli... Lack of assurance of sterility; equipment failure led to potential breach in asceptic process. Class II Hospira Inc.
Sep 16, 2013 Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage ... Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the ... Class II Hospira, Inc.
Sep 16, 2013 1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., L... Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochlor... Class I Hospira, Inc.
Sep 5, 2013 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial,... Lack of Assurance of Sterility; potential for vial breakage Class II Hospira Inc.
Aug 30, 2013 Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx onl... Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as... Class I Hospira Inc.
Aug 29, 2013 5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, R... Presence of Particulate Matter; report of visible particulates in the glass ampule Class II Hospira Inc.
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.
Aug 12, 2013 Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Fo... Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials. Class II 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 20, 2013 Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, ... Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles f... 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.
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.

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.