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
Jan 24, 2019	LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date an...	Class II	US Compounding Inc
Jan 16, 2019	NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 ...	Labeling: Label mix-up	Class II	KRS Global Biotechnology, Inc
Jan 16, 2019	NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 ...	Labeling: Label mix-up	Class II	KRS Global Biotechnology, Inc
Jan 16, 2019	Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards,...	Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate S...	Class II	Rx Pak Division of McKesson Corporation
Jan 15, 2019	HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodiu...	Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/5...	Class II	Advanced Pharma Inc.
Jan 15, 2019	Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ...	Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.	Class II	Tris Pharma Inc.
Jan 15, 2019	Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ...	Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.	Class II	Tris Pharma Inc.
Jan 15, 2019	infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 m...	Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.	Class II	Tris Pharma Inc.
Dec 26, 2018	LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC...	Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel i...	Class III	Sun Pharmaceutical Industries, Inc.
Dec 11, 2018	Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: K...	Labeling: Wrong bar code	Class II	KVK-Tech, Inc.
Dec 11, 2018	Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno...	Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall...	Class I	Asclemed USA Inc. dba Enovachem
Dec 11, 2018	Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno...	Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall...	Class I	Asclemed USA Inc. dba Enovachem
Dec 10, 2018	Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as o...	Superpotent Drug: contains higher levels of Iron than labeled.	Class II	Gordon Laboratories
Nov 29, 2018	Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable So...	Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per ...	Class I	Advanced Pharma Inc.
Nov 15, 2018	SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 2...	Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state...	Class I	Fresenius Kabi USA, LLC
Nov 15, 2018	SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 2...	Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state...	Class I	Fresenius Kabi USA, LLC
Nov 9, 2018	Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl...	Labeling: Label mix-up - the label on the product may not match the formula in the bottle.	Class II	Ecolab Inc
Nov 9, 2018	Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl o...	Labeling: Label mix-up - the label on the product may not match the formula in the bottle.	Class II	Ecolab Inc
Nov 8, 2018	ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use v...	Labeling: Missing label; potential for missing primary container label on the vial.	Class III	Eli Lilly & Co
Nov 2, 2018	curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Ep...	Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use...	Class II	Bound Tree Medical, LLC
Nov 2, 2018	curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 ...	Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use...	Class II	Bound Tree Medical, LLC
Nov 2, 2018	Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarn...	Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use...	Class II	Bound Tree Medical, LLC
Nov 2, 2018	Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contai...	Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use...	Class II	Bound Tree Medical, LLC
Nov 1, 2018	Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe...	Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May...	Class III	Bound Tree Medical, LLC
Nov 1, 2018	curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains...	Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 e...	Class II	Bound Tree Medical, LLC
Oct 26, 2018	Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), F...	Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and ...	Class I	Dr. Reddy's Laboratories, Inc.
Oct 23, 2018	Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg,...	Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser cont...	Class II	Janssen Pharmaceuticals, Inc.
Oct 23, 2018	Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28...	Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser cont...	Class II	Janssen Pharmaceuticals, Inc.
Oct 3, 2018	Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g T...	Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Hep...	Class II	Pfizer Inc.
Sep 28, 2018	Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Su...	Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration dat...	Class II	Tailor Made Compounding
Sep 25, 2018	Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw ...	Labeling Not Elsewhere Classified: Misbranding.	Class III	Right Value Drug Stores, Inc.
Sep 25, 2018	Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pi...	Labeling Not Elsewhere Classified: Misbranding.	Class III	Right Value Drug Stores, Inc.
Sep 25, 2018	Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw ...	Labeling Not Elsewhere Classified: Misbranding.	Class III	Right Value Drug Stores, Inc.
Sep 25, 2018	Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top p...	Labeling Not Elsewhere Classified: Misbranding.	Class III	Right Value Drug Stores, Inc.
Sep 18, 2018	Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 m...	Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging com...	Class III	Xiromed LLC
Sep 17, 2018	treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for...	Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabel...	Class III	Otsuka Pharmaceutical Development & Commerciali...
Sep 17, 2018	treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for ...	Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabel...	Class III	Otsuka Pharmaceutical Development & Commerciali...
Sep 17, 2018	robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, ...	Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly...	Class I	Endo Pharmaceuticals, Inc.
Aug 27, 2018	Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3...	Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.	Class III	Mylan Pharmaceuticals Inc.
Aug 23, 2018	Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL O...	Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the i...	Class II	Pfizer Global Supply
Aug 22, 2018	THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/...	CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels...	Class II	Syntec Pharma Corp
Aug 22, 2018	THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothy...	CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels...	Class II	Syntec Pharma Corp
Aug 21, 2018	Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufact...	Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets US...	Class I	Accord Healthcare, Inc.
Aug 21, 2018	Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary cont...	Class III	Mayne Pharma Inc
Aug 15, 2018	Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero...	Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 ...	Class I	Hetero Labs Limited Unit V
Aug 3, 2018	Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/2 grain (30 mg), 100...	Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph...	Class I	Westminster Pharmaceuticals LLC
Aug 3, 2018	Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100...	Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph...	Class I	Westminster Pharmaceuticals LLC
Aug 3, 2018	Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Dis...	Subpotent drug: The product active ingredient level not matching the exact levels indicated on th...	Class III	Huijing (Shanghai) Bio-tech Co., Ltd.
Aug 3, 2018	Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg),...	Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph...	Class I	Westminster Pharmaceuticals LLC
Aug 3, 2018	Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-...	Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph...	Class I	Westminster Pharmaceuticals 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.