Browse Drug Recalls
515 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 515 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 515 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 11, 2014 | 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container ba... | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Class I | Baxter Healthcare Corp. |
| Jul 11, 2014 | Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Con... | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics | Class I | Baxter Healthcare Corp. |
| Jul 11, 2014 | 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Si... | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Class I | Baxter Healthcare Corp. |
| 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 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 16, 2014 | Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500... | Presence of Particulate Matter: Complaints received of discolored solution identified as subvisib... | Class II | Baxter Healthcare Corp. |
| Jun 2, 2014 | Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only... | Presence of Particulate Matter: Product failed the appearance for the presence of visible particl... | Class I | Alexion Pharmaceuticals, Inc. |
| May 20, 2014 | Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA ... | Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solu... | Class II | Cambrex Charles City 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. |
| May 12, 2014 | 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, B... | Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes | Class I | Baxter Healthcare Corp. |
| May 12, 2014 | COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vi... | Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic c... | Class I | Bristol-Meyers Squibb |
| May 2, 2014 | Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= pheny... | Presence of Particular Matter: Potential glass delamination and consistent with glass particulate... | Class II | Fresenius Kabi USA, LLC |
| May 2, 2014 | Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenyto... | Presence of Particular Matter: Potential glass delamination and consistent with glass particulate... | Class II | Fresenius Kabi USA, LLC |
| Apr 24, 2014 | Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G342... | Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting ... | Class II | Baxter Healthcare Corp. |
| Apr 21, 2014 | 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufacture... | Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irriga... | Class II | Baxter Healthcare Corp. |
| 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 17, 2014 | CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufact... | Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard. | Class I | Cubist Pharmaceuticals, 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 17, 2014 | Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pha... | Presence of Particulate Matter | Class II | John W Hollis Inc |
| Mar 14, 2014 | VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/via... | Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate. | Class I | Shire Human Genetic Therapies, Inc. |
| Mar 11, 2014 | Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5m... | Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochlo... | Class II | Paddock Laboratories, LLC |
| Feb 19, 2014 | Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarat... | Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug. | Class III | Gilead Sciences, Inc. |
| Feb 14, 2014 | etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 m... | Presence of Particulate Matter: Potential for small black particles to be present in individual v... | Class II | Agila Specialties Private Ltd. |
| Feb 14, 2014 | Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratorie... | Presence of Particulate Matter: During a review of retain samples, the firm found a glass particu... | Class I | Ben Venue Laboratories Inc |
| Feb 13, 2014 | BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-... | Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPiv... | Class II | Healix Infusion Therapy, Inc. |
| Feb 11, 2014 | Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Fl... | Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag ... | Class I | Baxter Healthcare Corp. |
| 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. |
| 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 23, 2013 | Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactur... | Presence of Foreign Substance; metal particulates were visually observed in the tablets. | Class II | Watson Laboratories 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. |
| Nov 21, 2013 | Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Conta... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, C... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No.... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX... | Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due t... | Class I | Baxter Healthcare Corp. |
| Nov 21, 2013 | 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB C... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx... | Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to... | Class I | Baxter Healthcare Corp. |
| Nov 21, 2013 | Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 m... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Containe... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 18, 2013 | Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1... | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% De... | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Class I | Baxter Healthcare Corp. |
| Nov 18, 2013 | Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL... | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Class I | Baxter Healthcare Corp. |
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.