Browse Drug Recalls

2,012 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,012 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 2,012 FDA drug recalls.

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DateProductReasonClassFirm
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
Aug 3, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-c... Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... Class I Westminster Pharmaceuticals LLC
Jul 26, 2018 Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grape... Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label Class III Right Value Drug Stores, Inc.
Jul 20, 2018 NET Remedies #11 (Lilac Label) Homeopathic Preparation, Oral Liquid, 57 mL, M... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #9 (Fuschia Label) Homeopathic Preparation, Oral Liquid, 57 mL, ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #8 (Royal Blue Label) Homeopathic Preparation, Oral Liquid, 57 m... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #1 (Yellow Label) Homeopathic Preparation, Oral Liquid, 57 mL, M... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #25 (Yellow, White and Purple Label) Homeopathic Preparation, Or... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #20 (Red, White and Blue Label) Homeopathic Preparation, Oral Li... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #3 (Blue Label) Homeopathic Preparation, Oral Liquid, 57 mL, Man... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #24 (Blue, White and Purple Label) Homeopathic Preparation, Oral... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #7 (Aqua Blue Label) Homeopathic Preparation, Oral Liquid, 57 mL... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #8 Allergy (Blue Label) Homeopathic Preparation, Oral Liquid, 57... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #5 (Red Label) Homeopathic Preparation, Oral Liquid, 57 mL, Manu... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #6 (Orange Label) Homeopathic Preparation, Oral Liquid, 57 mL, M... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #10 (Maroon Label) Homeopathic Preparation, Oral Liquid, 57 mL, ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #12 (Pink Label) Homeopathic Preparation, Oral Liquid, 57 mL, Ma... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 NET Remedies #4 (Green Label) Homeopathic Preparation, Oral Liquid, 57 mL, Ma... Microbial contamination Class I King Bio Inc.
Jul 10, 2018 Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dos... Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or e... Class III Valeant Pharmaceuticals North America LLC
Jul 3, 2018 Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL),... CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a... Class II Medi-Fare Drug and Home Health Center
Jun 29, 2018 Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 m... Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 ... Class I Fagron Compounding Services LLC dba Fagron Ster...
Jun 29, 2018 Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 m... Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 ... Class I Fagron Compounding Services LLC dba Fagron Ster...
Jun 20, 2018 fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL ... Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated ... Class II Advanced Pharma Inc.
Jun 13, 2018 Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Lax... Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ... Class III LUPIN SOMERSET
Jun 8, 2018 TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Q... Labeling: Incorrect or Missing Lot and/or Exp Date. Class III Qualgen, LLC
Jun 8, 2018 ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualge... Labeling: Incorrect or Missing Lot and/or Exp Date. Class III Qualgen, LLC
May 24, 2018 Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-coun... Labeling: Missing Label Class III LUPIN SOMERSET
Apr 26, 2018 Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473... Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to... Class III Sun Pharmaceutical Industries, Inc.
Apr 24, 2018 Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct f... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 24, 2018 Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannet... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 24, 2018 Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laborat... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 24, 2018 Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pa... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 24, 2018 Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pa... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 20, 2018 Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-co... Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg containe... Class II Exela Pharma Sciences LLC
Apr 13, 2018 Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed... Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement o... Class III Boiron Inc.
Mar 19, 2018 Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Qual... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Lake Erie Medical & Surgical Supply Inc
Mar 19, 2018 Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by:... Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One... Class III Glenmark Pharmaceuticals Inc., USA
Mar 15, 2018 All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Co... Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange... Class I Bayer HealthCare Pharmaceuticals, Inc.
Mar 9, 2018 Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), pa... Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its lab... Class III Alva-Amco Pharmacal Companies., Inc.
Mar 5, 2018 Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded ... Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which con... Class III Pine Pharmaceuticals, LLC
Feb 28, 2018 Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count... Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to ... Class III Osmotica Pharmaceutical Corp

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.