Browse Drug Recalls

116 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 116 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 116 FDA drug recalls.

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DateProductReasonClassFirm
Jun 7, 2022 Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cu... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Mar 24, 2022 MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packag... CGMP Deviations: Failure to properly investigate failed microbial testing. Class II Plastikon Healthcare LLC
Mar 24, 2022 Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 ... CGMP Deviations: Failure to properly investigate failed microbial testing. Class II Plastikon Healthcare LLC
Mar 24, 2022 Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per ... CGMP Deviations: Failure to properly investigate failed microbial testing. Class II Plastikon Healthcare LLC
Mar 24, 2022 MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packag... Microbial Contamination of Non-Sterile Products Class I Plastikon Healthcare LLC
Mar 24, 2022 Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 ... Microbial Contamination of Non-Sterile Products Class I Plastikon Healthcare LLC
Feb 28, 2022 PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 ... Failed Dissolution Specifications Class II The Harvard Drug Group
Feb 24, 2022 hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister pa... Failed Impurities/Degradation Specifications: Out of specification result obtained during routine... Class II The Harvard Drug Group
Oct 26, 2021 Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1... CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... Class II Perrigo Company PLC
Oct 12, 2021 Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate... Failed Moisture Limits Class III SUN PHARMACEUTICAL INDUSTRIES INC
Oct 5, 2021 Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S... Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it ... Class III A-S Medication Solutions LLC.
Aug 6, 2021 Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx onl... Failed Dissolution Specifications Class II The Harvard Drug Group
Aug 3, 2021 Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distribute... Failed Impurities/Degradation Specifications Class II The Harvard Drug Group
Jul 29, 2021 Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, D... Failed Dissolution Specifications Class II The Harvard Drug Group
Jul 27, 2021 MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 coun... Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... Class II Perrigo Company PLC
Jul 2, 2021 NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 cou... Failed Dissolution Specification: Out of specification for dissolution during routine stability t... Class II The Harvard Drug Group
Mar 15, 2021 Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 2, 2021 Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottle... Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 co... Class I A-S Medication Solutions LLC.
Nov 18, 2020 Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, M... Failed Dissolution Specifications: Out of specification for dissolution. Class II The Harvard Drug Group
Jun 12, 2020 Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (1... CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established... Class II The Harvard Drug Group
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
Apr 24, 2020 Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per un... Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine st... Class III The Harvard Drug Group
Feb 27, 2020 Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dos... Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... Class III The Harvard Drug Group
Feb 27, 2020 Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit do... Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... Class III The Harvard Drug Group
Feb 27, 2020 Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit do... Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... Class III The Harvard Drug Group
Feb 27, 2020 Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit do... Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... Class III The Harvard Drug Group
Feb 3, 2020 Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reduce... Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement... Class II Contract Pharmacal Corporation
Dec 13, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III The Harvard Drug Group
Sep 18, 2019 Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30... Microbial Contamination of Non-Sterile Product. Class II GCP Laboratories Inc
Aug 30, 2019 Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit ... Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerob... Class I Plastikon Healthcare LLC
Jun 10, 2019 Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextrometho... CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Preferred Pharmaceuticals, Inc
May 21, 2019 Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough sup... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, US... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, US... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fa... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydra... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
Apr 24, 2019 DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-un... cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. Class II MAJOR PHARMACEUTICALS
Jan 10, 2019 Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II MAJOR PHARMACEUTICALS
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 18, 2018 Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pha... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II MAJOR PHARMACEUTICALS
Jul 18, 2018 Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Phar... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II MAJOR PHARMACEUTICALS
Jun 26, 2018 Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per c... Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... Class III MAJOR PHARMACEUTICALS
Jun 26, 2018 Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per car... Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... Class III MAJOR PHARMACEUTICALS
Sep 26, 2017 Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx ... Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity. Class II The Harvard Drug Group
Sep 13, 2017 Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in ... Failed Impurities/Degradation Specifications. Class III Vi-Jon, 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.