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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
Dec 3, 2014 MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake F... Failed Stability Specifications: Product is subpotent and has out of specification known and unkn... Class I Hospira Inc.
Nov 25, 2014 Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx... Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when st... Class III 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.
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 Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop V... 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 11, 2014 HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.... Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between ... Class I 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.
Jan 10, 2014 DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, ... Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the... Class I Hospira Inc.
Jan 9, 2014 Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in... Lack of Assurance of Sterility; potential leakage from administrative port. Class II Hospira Inc.
Jan 9, 2014 Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Mainten... Lack of Assurance of Sterility; potential leakage from administrative port. 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 24, 2013 Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only,... Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) w... Class II Hospira Inc.
Sep 24, 2013 Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx On... Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) we... Class II 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.

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.