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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Feb 23, 2018 | Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%... | Labeling: Label mix-up | Class II | Bayer HealthCare Pharmaceuticals, Inc. |
| Feb 22, 2018 | labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Us... | Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indica... | Class III | SCA Pharmaceuticals, LLC. |
| Feb 21, 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... | Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmoti... | Class II | Renaissance Lakewood, LLC |
| Feb 20, 2018 | Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multid... | Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and ... | Class II | Hospira Inc. A Pfizer Company |
| Feb 15, 2018 | PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodi... | Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. | Class II | Medline Industries Inc |
| Feb 9, 2018 | Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 5... | Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Tors... | Class II | Apace KY LLC |
| Feb 5, 2018 | Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canad... | Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitt... | Class III | Genentech, Inc. |
| Feb 2, 2018 | NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, ... | Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classificati... | Class III | ALLERGAN |
| Jan 26, 2018 | Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules,... | Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... | Class I | Primus Pharmaceuticals, Inc. |
| Jan 26, 2018 | Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules,... | Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... | Class I | Primus Pharmaceuticals, 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.