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Browse Drug Recalls

188 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 188 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 188 FDA drug recalls.

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DateProductReasonClassFirm
Oct 13, 2022 PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, U... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, R... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reli... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manu... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tub... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Ma... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, ... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL droppe... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufacture... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dro... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactur... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-7... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufact... CGMP Deviations: Class II Akorn, Inc.
Sep 21, 2022 Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-... Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... Class II Akorn, Inc.
Sep 21, 2022 Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Ako... Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... Class II Akorn, Inc.
Aug 31, 2022 Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) t... cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop... Class II Akorn, Inc.
Aug 31, 2022 Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufact... cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop... Class II Akorn, Inc.
Aug 8, 2022 Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials,... Identification of an unknown impurity at the 12-month stability point. Further investigation has ... Class III Akorn, Inc
Jun 13, 2022 Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amb... Defective container: defect prevents product from dispensing as intended. Class II Akorn, Inc.
Jun 10, 2022 Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl... Defective Delivery System: Potential defect that could prevent the product from dispensing as int... Class II Akorn, Inc.
Jun 3, 2022 Olopatadine HCl, Ophthalmic Solution, USP, 0.2%, 2.5 mL per dropper bottle, R... Failed impurity/degradation specifications: Out of specification for 2-HMP (a product leachable) ... Class III Akorn, Inc.
Apr 15, 2022 Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per b... Failed viscosity specification - product was below specificcation Class III Akorn, Inc.
Jan 5, 2022 Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous an... Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. Class II Akorn, Inc.
Dec 3, 2021 Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bo... Labeling: Missing Label Class III Akorn, Inc.
Dec 3, 2021 Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx o... Labeling: Missing Label Class III Akorn, Inc.
Oct 4, 2021 Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dro... Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stabil... Class II Akorn, Inc.
Sep 8, 2021 TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 3... Lack of Assurance of Sterility Class II Akorn, 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 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.
Mar 15, 2021 COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzo... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The E... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health 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.
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.
Sep 3, 2020 Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL... CGMP Deviations Class II Akorn, Inc.
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.
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.
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.
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.
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

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.