Browse Drug Recalls
1,317 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,317 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 1,317 FDA drug recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 17, 2017 | VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Co... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class II | Pharmedium Services, LLC |
| Feb 17, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Servi... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 17, 2017 | VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227,... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class II | Pharmedium Services, LLC |
| Feb 17, 2017 | Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service... | Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. | Class III | Pharmedium Services, LLC |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium ... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlo... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlo... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 15, 2017 | Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Pharmedium Services Llc |
| Feb 10, 2017 | METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible ... | Lack of Sterility Assurance: customer report of leaking bag | Class II | Hospira Inc., A Pfizer Company |
| Feb 2, 2017 | Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Cover... | Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Ca... | Class III | Sage Products Inc |
| Jan 27, 2017 | Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactur... | Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Jan 27, 2017 | Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 ... | Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of... | Class III | Pharmedium Services, LLC |
| 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 |
| Jan 13, 2017 | Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 ... | Failed Stability Specifications: confirmed out of specification results obtained during refrigera... | Class II | AbbVie Inc. |
| Dec 16, 2016 | MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per c... | Failed Impurities/Degradation Specifications | Class II | Fresenius Kabi USA, LLC |
| Dec 7, 2016 | Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10... | Subpotent Drug: Out of specification result for pramoxine hydrochloride | Class III | Novum Pharma, LLC |
| Dec 6, 2016 | Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... | Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. | Class II | Baxter Healthcare Corporation |
| Dec 6, 2016 | 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx on... | Discoloration: there were customer reports of yellow discolored solution. The yellow coloration i... | Class II | Baxter Healthcare Corporation |
| Nov 14, 2016 | Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60... | Failed Stability Specifications; out-of specification value for homogeneity / phase separation. | Class II | Akorn Inc |
| 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. |
| Oct 21, 2016 | Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akor... | Subpotent Drug: concentration of product is less than labeled amount. | Class II | Akorn Inc |
| Oct 12, 2016 | Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx onl... | Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the fir... | Class II | Pharmedium Services, LLC |
| Sep 28, 2016 | Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10... | Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related ... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Sep 28, 2016 | Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10... | Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related ... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| 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 |
| Jul 29, 2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnate... | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... | Class II | Sage Products LLC |
| Jul 29, 2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnate... | Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia ce... | Class I | Sage Products LLC |
| Jul 29, 2016 | 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further p... | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... | Class II | Sage Products LLC |
| Jul 27, 2016 | Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, ... | Failed impurities/degradation specifications: product was out of specification for unknown impuri... | Class III | Akorn, Inc. |
| 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. |
| Jun 23, 2016 | Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake ... | Crystallization: Product contains particulate identified to be crystallized active ingredient. | Class II | Hospira Inc. |
| Jun 13, 2016 | Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - ... | Presence of Particulate Matter; The firm received two product complaints for small, dark particul... | Class II | Sagent Pharmaceuticals Inc |
| May 17, 2016 | Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL b... | Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability | Class II | Akorn, Inc. |
| May 16, 2016 | Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMED... | Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label s... | Class II | Pharmedium Services, LLC |
| May 6, 2016 | Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hosp... | Presence of Particulate Matter: Cardboard | Class II | Hospira Inc. |
| May 5, 2016 | 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in... | Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... | Class II | Pharmedium Services, LLC |
| May 5, 2016 | 4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in ... | Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... | Class II | Pharmedium Services, LLC |
| May 5, 2016 | 2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0... | Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... | Class II | Pharmedium Services, LLC |
| May 5, 2016 | 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0... | Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... | Class II | Pharmedium Services, LLC |
| May 5, 2016 | 2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.... | Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... | Class II | Pharmedium Services, LLC |
| May 5, 2016 | 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) i... | Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... | Class II | Pharmedium Services, LLC |
| May 5, 2016 | 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0... | Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... | Class II | Pharmedium Services, LLC |
| May 5, 2016 | 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0... | Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... | Class II | Pharmedium Services, LLC |
| May 5, 2016 | 0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Me... | Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... | Class II | Pharmedium Services, LLC |
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.