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Browse Drug Recalls

1,301 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,301 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 1,301 FDA drug recalls in IL.

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DateProductReasonClassFirm
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
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.125% 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 20 mcg/mL HYDROmorphone HCl and 0.075% 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 2.5 mcg/mL Fentanyl Citrate and 0.15% 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 2.5 mcg/mL Fentanyl Citrate and 0.0312% 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 2.5 mcg/mL Fentanyl Citrate 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 5 mcg/mL HYDROmorphone HCl 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 2.5 mcg/mL Fentanyl Citrate and 0.0625% 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 10 mcg/mL Fentanyl Citrate and 0.075% 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 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 2... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 20 mcg/mL HYDROmorphone HCl and 0.06% 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 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 m... 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 HYDROmorphone HCl and 0.075% 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 10 mcg/mL HYDROmorphone HCl and 0.0625% 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 3 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 2 mcg/mL Fentanyl Citrate and 0.06% 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 2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in... 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.