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.

Clear

Date	Product	Reason	Class	Firm
Dec 16, 2019	Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx o...	Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of th...	Class II	Akorn Inc
Dec 16, 2019	NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 ...	Subpotent Drug	Class III	Pharmedium Services, LLC
Dec 16, 2019	NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 ...	Subpotent Drug	Class III	Pharmedium Services, LLC
Nov 19, 2019	0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare...	Lack of Assurance of Sterility: Product has the potential to leak.	Class II	Baxter Healthcare Corporation
Nov 15, 2019	MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3...	Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP ...	Class II	Akorn, Inc.
Nov 13, 2019	Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per c...	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.	Class II	Precision Dose Inc.
Oct 25, 2019	LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira...	Presence of Particulate Matter.	Class I	ICU Medical Inc
Oct 25, 2019	0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira...	Presence of Particulate Matter.	Class I	ICU Medical Inc
Sep 23, 2019	Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl o...	Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14	Class II	Morton Grove Pharmaceuticals, Inc.
Sep 20, 2019	Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx ...	Lack of Assurance of Sterility: Out of specification results for container closure test which can...	Class II	Akorn, Inc.
Sep 17, 2019	Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufac...	cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tub...	Class II	Akorn, Inc.
Aug 6, 2019	Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, Fo...	Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) an...	Class III	Akorn, Inc.
Aug 6, 2019	Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 1...	Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-as...	Class III	Akorn, Inc.
Aug 6, 2019	Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, Fo...	Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-as...	Class III	Akorn, Inc.
Jul 18, 2019	0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter...	Lack of Assurance of Sterility: Bags have potential to leak.	Class II	Baxter Healthcare Corporation
Jun 28, 2019	Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 ...	Presence of Particulate Matter; glass particulates	Class I	Fresenius Kabi USA, LLC
Jun 13, 2019	Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured ...	Failed Stability Specifications	Class II	Baxter Healthcare Corporation
Jun 7, 2019	Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsu...	Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primar...	Class III	Akorn Inc
Apr 30, 2019	Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL V...	Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufac...	Class II	Sagent Pharmaceuticals Inc
Apr 23, 2019	Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per car...	Failed impurities/degradation specification: Out of Specification result for total impurity at 4....	Class III	Akorn Inc
Mar 28, 2019	Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx on...	Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was ob...	Class III	Akorn, Inc.
Mar 26, 2019	Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/...	Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufact...	Class III	Medi-Physics Inc. dba GE Healthcare
Mar 12, 2019	Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, ...	Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testi...	Class II	Akorn Inc
Feb 22, 2019	Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manu...	Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individ...	Class II	Akorn, Inc.
Feb 4, 2019	0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hos...	CGMP Deviations	Class II	ICU Medical Inc
Feb 4, 2019	Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl...	Failed Stability Specification: out of specification results for Sodium Perborate	Class II	Akorn Inc
Feb 1, 2019	Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx...	Presence of Particulate Matter: particulate matter identified as copper salts	Class I	Mylan Institutional Inc
Jan 25, 2019	Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) an...	Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month ...	Class III	Akorn Inc
Jan 18, 2019	Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for...	Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected durin...	Class II	Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 2, 2019	Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro...	Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.	Class II	Baxter Healthcare Corporation
Dec 20, 2018	COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol ...	Failed Stability Specifications: out of specification results for opalescence at 7 month stabilit...	Class III	Akorn Inc
Dec 5, 2018	Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in...	Sub-potent	Class II	Pharmedium Services, LLC
Dec 5, 2018	Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% i...	Sub-potent	Class II	Pharmedium Services, LLC
Nov 6, 2018	AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by:...	Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month ...	Class III	Takeda Development Center Americas, Inc.
Oct 29, 2018	Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 ple...	Failed Impurities/Degradation Specifications; out of specification results observed for other ind...	Class III	Akorn, Inc.
Oct 15, 2018	Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile si...	Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the imp...	Class III	Baxter Healthcare Corporation
Oct 8, 2018	Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Onl...	Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.	Class II	Akorn, Inc.
Oct 8, 2018	5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC...	Lack of Assurance of Sterility; bags have the potential to leak	Class II	ICU Medical Inc
Oct 8, 2018	0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 15...	Lack of Assurance of Sterility; bags have the potential to leak	Class II	ICU Medical Inc
Sep 25, 2018	Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 360...	Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce...	Class III	Baxter Healthcare Corporation
Sep 17, 2018	SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g t...	Microbial Contamination of Non-Sterile Product	Class II	Medline Industries Inc
Sep 10, 2018	Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 1...	Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes o...	Class II	Takeda Development Center Americas, Inc.
Sep 6, 2018	0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare ...	cGMP Deviation	Class II	Baxter Healthcare Corporation
Aug 24, 2018	Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For...	Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified ...	Class II	Akorn, Inc.
Aug 21, 2018	0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Co...	CGMP Deviations	Class II	Baxter Healthcare Corporation
Aug 14, 2018	Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister c...	Failed Impurities/Degradation Specifications; out of specification results for related compound p...	Class III	Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Aug 8, 2018	Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle...	Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-...	Class III	Akorn, Inc.
Aug 1, 2018	Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% ...	Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce...	Class III	Baxter Healthcare Corporation
Aug 1, 2018	Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% ...	Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce...	Class III	Baxter Healthcare Corporation
Aug 1, 2018	Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by...	Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impuri...	Class II	Akorn, 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.