Browse Drug Recalls

55 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 55 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 55 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Sep 22, 2023	Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx onl...	Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two ...	Class III	West-Ward Columbus Inc
Mar 15, 2021	Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) ...	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Class II	Cardinal Health Inc.
Jul 22, 2020	Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr....	Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.	Class III	West-Ward Columbus Inc
May 22, 2020	Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose carto...	Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf l...	Class II	The Harvard Drug Group
May 13, 2020	Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. b...	Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degra...	Class III	West-Ward Columbus Inc
May 13, 2020	Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC ...	Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf l...	Class II	West-Ward Columbus Inc
Sep 9, 2019	Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, ...	Failed Impurities/Degradation Specificattion	Class II	West-Ward Columbus Inc
Jul 30, 2018	Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit do...	Failed Dissolution Specifications	Class II	MAJOR PHARMACEUTICALS
Jul 24, 2018	Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufact...	Failed Dissolution Specifications:	Class II	West-Ward Columbus Inc
Jul 24, 2018	Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufac...	Failed Dissolution Specifications:	Class II	West-Ward Columbus Inc
Nov 6, 2017	Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Via...	Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone...	Class III	West-Ward Pharmaceuticals Corp.
Nov 6, 2017	Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-...	Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone...	Class III	West-Ward Pharmaceuticals Corp.
Apr 20, 2017	Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b...	Labeling: Label Mixup; potentially mislabeled	Class II	C. O. Truxton
Apr 20, 2017	Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured b...	Labeling: Label Mixup; potentially mislabeled	Class II	C. O. Truxton
Apr 20, 2017	Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b...	Labeling: Label Mixup; potentially mislabeled	Class II	C. O. Truxton
Apr 20, 2017	Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b...	Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital...	Class I	C. O. Truxton
Apr 20, 2017	Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured b...	Labeling: Label Mixup; potentially mislabeled	Class I	C. O. Truxton
Dec 14, 2016	Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spra...	Defective Delivery System: out of specification result for droplet size distribution at the d90 m...	Class III	Roxane Laboratories, Inc.
Nov 17, 2016	SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5...	Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 mon...	Class III	West-Ward Pharmaceuticals Corp.
Nov 4, 2016	Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted)...	Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the stren...	Class III	West-Ward Pharmaceuticals Corp.
Oct 3, 2016	PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-War...	Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.	Class II	West-Ward Pharmaceutical
Oct 3, 2016	Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-War...	Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolu...	Class II	West-Ward Pharmaceuticals Corp.
Aug 18, 2016	Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when re...	Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of...	Class III	West-Ward Pharmaceuticals Corp.
Nov 10, 2015	Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuti...	Labeling: Not elsewhere classified. NDC number is incorrect on the container.	Class III	Northwind Pharmaceuticals LLC
May 13, 2015	Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx On...	Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).	Class III	West-Ward Pharmaceutical Corp.
Feb 16, 2015	Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5...	Failed Impurities/Degradation Specifications; 12 month stability testing.	Class III	West-Ward Pharmaceutical Corporation
Oct 2, 2014	VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-co...	Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.	Class II	West-Ward Pharmaceutical Corp.
May 20, 2014	Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, ND...	Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month ti...	Class II	West-Ward Pharmaceutical Corp.
Nov 7, 2013	Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward ...	Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of t...	Class II	West-Ward Pharmaceutical Corp.
Sep 23, 2013	Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Do...	Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to d...	Class II	West-Ward Pharmaceutical Corp.
Sep 23, 2013	Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single D...	Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to d...	Class II	West-Ward Pharmaceutical Corp.
Jul 30, 2013	Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (N...	Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other U...	Class II	West-Ward Pharmaceutical Corp.
Jul 30, 2013	Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10...	Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets	Class II	West-Ward Pharmaceutical Corp.
Jun 17, 2013	Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenob...	Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product becaus...	Class II	Physicians Total Care, Inc.
Jun 4, 2013	VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tabl...	Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification resu...	Class II	West-Ward Pharmaceutical Corp.
May 16, 2013	West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bott...	Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets containe...	Class II	West-Ward Pharmaceutical Corp.
May 16, 2013	West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bott...	Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks ...	Class II	West-Ward Pharmaceutical Corp.
May 13, 2013	Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use...	Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpu...	Class III	West-ward Pharmaceutical Corp.
Mar 18, 2013	Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), R...	Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration...	Class II	West-ward Pharmaceutical Corp.
Mar 18, 2013	Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, ...	Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.	Class II	West-ward Pharmaceutical Corp.
Feb 6, 2013	Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured fo...	Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg...	Class II	West-ward Pharmaceutical Corp.
Jan 7, 2013	Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, U...	Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.	Class II	West-ward Pharmaceutical Corp.
Jan 7, 2013	Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactu...	Subpotent Drug	Class III	West-ward Pharmaceutical Corp.
Dec 17, 2012	Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 4...	Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of th...	Class II	L. Perrigo Co.
Dec 7, 2012	Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottl...	Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.	Class II	West-ward Pharmaceutical Corp.
Dec 7, 2012	Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bo...	Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tab...	Class II	West-ward Pharmaceutical Corp.
Dec 7, 2012	Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (N...	Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant ...	Class II	West-ward Pharmaceutical Corp.
Dec 5, 2012	PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (...	Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the t...	Class II	West-ward Pharmaceutical Corp.
Dec 5, 2012	PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (...	Presence of Foreign Substance: A complaint was received for black specks identified as stainless ...	Class II	West-ward Pharmaceutical Corp.
Dec 4, 2012	Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-...	Failed Dissolution Specifications; 36 month stability timepoint	Class II	West-ward 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.