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.

Date	Product	Reason	Class	Firm
Sep 3, 2021	Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP...	CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin...	Class II	Morton Grove Pharmaceuticals, Inc.
Sep 3, 2021	Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, M...	CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin...	Class II	Morton Grove Pharmaceuticals, Inc.
Sep 3, 2021	Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, ...	Failed Impurities/Degradation Specifications	Class III	Meitheal Pharmaceuticals Inc
Sep 3, 2021	AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible co...	Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous ...	Class I	ICU Medical Inc
Sep 3, 2021	Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/...	CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin...	Class II	Morton Grove Pharmaceuticals, Inc.
Aug 13, 2021	Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 m...	Failed impurities/degradation specification: Out of Specification for an unknown impurity observe...	Class II	Akorn, Inc.
Aug 6, 2021	Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For...	Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does ...	Class II	XELLIA PHARMACEUTICALS USA, LLC
Aug 6, 2021	Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, Fo...	Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does ...	Class II	XELLIA PHARMACEUTICALS USA, LLC
Aug 2, 2021	Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe...	Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stabil...	Class II	Akorn, Inc.
Jun 25, 2021	Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Inje...	Low out of specification results for epinephrine assay.	Class II	Fresenius Kabi USA LLC
May 14, 2021	READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) D...	Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.	Class III	Medline Industries Inc
May 3, 2021	1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose v...	Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, U...	Class I	PFIZER, INC
May 3, 2021	0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL ...	Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, U...	Class I	PFIZER, INC
May 3, 2021	Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 2...	Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 co...	Class III	Mylan Institutional LLC
Mar 11, 2021	Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial pac...	Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may res...	Class II	Sagent Pharmaceuticals Inc
Mar 10, 2021	aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, pa...	CGMP deviations: Product being recalled as it was made in the same facility where contamination w...	Class II	China Gel Inc
Mar 10, 2021	CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as...	CGMP deviations: Product being recalled as it was made in the same facility where contamination w...	Class II	China Gel Inc
Mar 10, 2021	CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, pack...	CGMP deviations: Product being recalled as it was made in the same facility where contamination w...	Class II	China Gel Inc
Mar 9, 2021	0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manu...	Presence of particulate matter.one confirmed customer report of particulate matter within two se...	Class II	ICU Medical Inc
Mar 8, 2021	Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose...	Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed ...	Class II	Akorn, Inc.
Mar 2, 2021	Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottle...	Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 co...	Class I	A-S Medication Solutions LLC.
Jan 27, 2021	Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dos...	Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain t...	Class I	Meitheal Pharmaceuticals Inc
Jan 1, 2021	Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit ...	cGMP deviations: The firm was notified of the manufacturer's expanded recall.	Class II	Precision Dose Inc.
Dec 28, 2020	Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI...	Defective container: Customer complaints for oral solution leaking from bottles.	Class II	Akorn, Inc.
Dec 28, 2020	Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only...	cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia...	Class II	Sunstar Americas, Inc.
Dec 23, 2020	Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ...	Presence of Particulate Matter - found in reserve sample vials at the firm.	Class I	Fresenius Kabi USA, LLC
Dec 17, 2020	Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), package...	Presence of Particulate Matter - found in reserve sample vials at the firm.	Class II	Fresenius Kabi USA, LLC
Dec 10, 2020	Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 m...	Subpotent Drug: Low out-of-specification assay results for the epinephrine component.	Class II	Fresenius Kabi USA, LLC
Dec 9, 2020	Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in...	Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, ...	Class II	Morton Grove Pharmaceuticals, Inc.
Nov 17, 2020	Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg...	Cross Contamination with other products: trace amounts of lidocaine	Class I	Fresenius Kabi USA, LLC
Nov 17, 2020	DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill...	Cross Contamination with Other Products: trace amounts of octreotide found during testing	Class III	Fresenius Kabi USA, LLC
Oct 27, 2020	Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only...	Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.	Class I	Sunstar Americas, Inc.
Oct 7, 2020	Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 m...	Presence of particulate matter in solution - black and transparent particles	Class II	Baxter Healthcare Corporation
Sep 3, 2020	Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL...	CGMP Deviations	Class II	Akorn, Inc.
Aug 17, 2020	Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-...	Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai...	Class I	Mylan Institutional LLC
Aug 17, 2020	Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose ...	Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai...	Class I	Mylan Institutional LLC
Jul 22, 2020	Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 m...	Cross Contamination with other products: trace amounts of lidocaine	Class I	Fresenius Kabi USA, LLC
Jul 13, 2020	Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx on...	Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly sta...	Class III	Fresenius Kabi USA, LLC
Jul 7, 2020	Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Ma...	Presence of Particulate Matter	Class I	Mylan Institutional LLC
Jun 5, 2020	Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx onl...	Discoloration: Out of Specification (OOS) result for APHA Color Test.	Class III	Akorn, Inc.
May 8, 2020	LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira...	Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matt...	Class I	ICU Medical Inc
May 5, 2020	Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only,...	Discoloration: Out-of-specification results for appearance obtained during routine stability test...	Class II	Mylan Institutional LLC
Apr 20, 2020	Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), package...	Presence of Particulate Matter - found in reserve sample vials at the firm.	Class II	Fresenius Kabi USA, LLC
Apr 20, 2020	Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ...	Presence of Particulate Matter - found in reserve sample vials at the firm.	Class I	Fresenius Kabi USA, LLC
Mar 25, 2020	Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per car...	Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4....	Class III	Akorn Inc
Feb 21, 2020	Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: A...	Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi...	Class III	Akorn, Inc.
Feb 21, 2020	CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distribu...	Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi...	Class III	Akorn, Inc.
Feb 21, 2020	Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, D...	Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi...	Class III	Akorn, Inc.
Dec 26, 2019	Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper ...	Chemical contamination; out of specification results obtained for equipment cleaning residue rins...	Class III	Akorn, Inc.
Dec 16, 2019	NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 ...	Subpotent Drug	Class III	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.