Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Jun 25, 2024	Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed b...	Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.	Class III	GLOBAL WIDGET LLC
Jun 25, 2024	Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz ...	Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.	Class III	GLOBAL WIDGET LLC
Jun 25, 2024	Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by...	Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.	Class III	GLOBAL WIDGET LLC
Jun 21, 2024	Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Package...	Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrec...	Class I	A-S Medication Solutions LLC
May 31, 2024	Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: ...	Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbita...	Class II	RemedyRepack Inc.
May 31, 2024	Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of ho...	Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferr...	Class III	Washington Homeopathic Products, Inc.
May 28, 2024	Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the fo...	Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum...	Class II	Consumer Product Partners, LLC
May 17, 2024	Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, ...	Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*,...	Class III	GlaxoSmithKline LLC
May 10, 2024	Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Rel...	Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on ...	Class III	Bryant Ranch Prepack, Inc.
May 10, 2024	Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), ...	Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP...	Class III	Bryant Ranch Prepack, Inc.
May 10, 2024	Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed),...	Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP...	Class III	Bryant Ranch Prepack, Inc.
May 10, 2024	Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixe...	Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP...	Class III	Bryant Ranch Prepack, Inc.
May 10, 2024	Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixe...	Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP...	Class III	Bryant Ranch Prepack, Inc.
May 7, 2024	Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectab...	Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.	Class II	PACIRA PHARMACEUTICALS INC
Apr 30, 2024	Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged...	Labeling: Wrong Barcode	Class III	Hikma Injectables USA Inc
Apr 29, 2024	Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL,...	Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.	Class I	Hikma Injectables USA Inc
Apr 20, 2024	Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, Thi...	Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate	Class I	Revive Rx LLC dba Revive Rx Pharmacy
Apr 2, 2024	Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent...	Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect...	Class III	X-Gen Pharmaceuticals Inc.
Apr 2, 2024	Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, ...	Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect...	Class III	X-Gen Pharmaceuticals Inc.
Mar 6, 2024	Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), ...	Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, spec...	Class II	B. Braun Medical Inc
Feb 12, 2024	CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1...	CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was...	Class II	MCKESSON CORPORATION
Feb 7, 2024	Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MF...	cGMP Deviations: Products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Feb 7, 2024	Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vi...	cGMP Deviations: Products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Feb 7, 2024	Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Sy...	cGMP Deviations: Products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Feb 5, 2024	Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when rec...	Labeling: Incorrect or Missing Package Insert	Class II	Lupin Pharmaceuticals Inc.
Jan 23, 2024	Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL),...	Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified ...	Class II	Baxter Healthcare Corporation
Jan 22, 2024	Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injectio...	Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyon...	Class II	IntegraDose Compounding Services LLC
Jan 17, 2024	Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Pack...	Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouc...	Class II	Henry Schein Inc. and Glove Club HSI Gloves Inc.
Jan 16, 2024	OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcoh...	CGMP Deviations: products may not conform to the labeled specifications.	Class II	Den-Mat Holdings, LLC
Jan 16, 2024	Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flav...	CGMP Deviations: products may not conform to the labeled specifications.	Class II	Den-Mat Holdings, LLC
Jan 10, 2024	Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Parabe...	Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while t...	Class II	MEDLINE INDUSTRIES, LP - Northfield
Jan 4, 2024	Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle,...	Labeling: Label Mix-up	Class I	Azurity Pharmaceuticals, Inc.
Dec 13, 2023	Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-C...	CGMP Deviations: Stability data does not support expiry date.	Class II	Private Label Partners, Inc.
Dec 11, 2023	NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx O...	Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.	Class II	Fagron, Inc
Dec 11, 2023	NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Onl...	Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.	Class II	Fagron, Inc
Dec 11, 2023	NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx O...	Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.	Class II	Fagron, Inc
Dec 11, 2023	NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only...	Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.	Class II	Fagron, Inc
Nov 13, 2023	Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) e...	Non-Sterility	Class I	Kilitch Healthcare India Limited
Nov 10, 2023	Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25...	Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL ...	Class III	Fagron Compounding Services
Nov 9, 2023	Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C;...	cGMP Deviations	Class II	Family Medical Supply Inc
Nov 7, 2023	Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: ...	Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen	Class II	Glenmark Pharmaceuticals Inc., USA
Nov 7, 2023	Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glen...	Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen	Class II	Glenmark Pharmaceuticals Inc., USA
Oct 30, 2023	V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioAc...	Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X i...	Class III	Grato Holdings, Inc.
Oct 20, 2023	Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only,...	Sub-potent Drug: Lower potency than labeled.	Class III	Zyla Life Sciences US Inc.
Oct 18, 2023	8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL S...	Presence of Particulate Matter: Silicone	Class I	Exela Pharma Sciences LLC
Oct 17, 2023	Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bott...	Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect bar...	Class III	AbbVie Inc.
Oct 5, 2023	Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail sto...	CGMP Deviations: OTC products were stored outside of labeled temperature requirements.	Class II	Dollar Tree Distribution, Inc.
Oct 4, 2023	Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06...	Labeling: Not Elsewhere Classified	Class III	Denver Solutions, LLC DBA Leiters Health
Oct 4, 2023	VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only...	Labeling: Not Elsewhere Classified	Class III	Denver Solutions, LLC DBA Leiters Health
Oct 4, 2023	VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx onl...	Labeling: Not Elsewhere Classified	Class III	Denver Solutions, LLC DBA Leiters Health

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.