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
Feb 17, 2026 Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs)... Defective container; inadequately sealed blister packaging. Class II The Harvard Drug Group LLC
Oct 10, 2025 Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx on... Failed Impurities/Degradation Specifications: an out of specification result obtained during rout... Class II The Harvard Drug Group LLC
Oct 10, 2025 Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only,... Failed Impurities/Degradation Specifications: an out of specification result obtained during rout... Class II The Harvard Drug Group LLC
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) ... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) bli... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) b... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) ... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Sep 12, 2025 Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) ... CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Sep 2, 2025 Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 T... Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product pack... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Sep 2, 2025 Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Ta... Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product pack... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Aug 20, 2025 Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Pack... CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jun 19, 2025 Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packag... Defective container; blister packaging inadequately sealed. Class II The Harvard Drug Group LLC
Jun 19, 2025 Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons,... Defective container; blister packaging inadequately sealed. Class II The Harvard Drug Group LLC
Apr 14, 2025 ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 ... CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended in... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Mar 4, 2025 Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Un... Failed Dissolution Specifications: Out of specification results obtained during routine stability... Class III The Harvard Drug Group LLC dba Major Pharmaceut...
Jan 30, 2025 Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablet... Failed Dissolution Specifications. Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jan 21, 2025 Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blist... Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results we... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jan 21, 2025 Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blist... Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results we... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jan 21, 2025 Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 bli... Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results we... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jan 13, 2025 Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses ... CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Dulo... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Nov 7, 2024 Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceutic... Failed Impurity/Degradation Specifications Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Nov 7, 2024 Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceutica... Failed Impurity/Degradation Specifications Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Nov 5, 2024 Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distribu... Failed Impurities/Degradation Specifications; during routine stability testing for impurities. Class III The Harvard Drug Group LLC dba Major Pharmaceut...
Jun 18, 2024 Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 bl... Failed dissolution specifications: out of specification result obtained during routine stability ... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
May 20, 2024 Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By:... Discoloration: Brownish tablets Class II Contract Pharmacal Corporation
Feb 9, 2024 HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 bli... an out of specification result obtained during routine stability testing for Impurities. There i... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Oct 31, 2023 Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I The Harvard Drug Group LLC dba Major Pharmaceut...
Oct 31, 2023 Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bo... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I The Harvard Drug Group LLC dba Major Pharmaceut...
Oct 23, 2023 Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL uni... Failed Content Uniformity Specifications Class I The Harvard Drug Group LLC dba Major Pharmaceut...
Sep 1, 2023 MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Jun 16, 2023 Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx onl... Packaging defect: blister packaging inadequately sealed. Class II The Harvard Drug Group
May 31, 2023 ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx on... Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg we... Class I The Harvard Drug Group LLC dba Major Pharmaceut...
Apr 24, 2023 Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablet... Product mixup: one foreign tablet found in product. Class III The Harvard Drug Group
Feb 23, 2023 Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx ... Packaging defect: observed packaging defect, blister packaging inadequately sealed. Class II The Harvard Drug Group
Jul 15, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 F... CGMP Deviations Class II Vi-Jon, LLC
Jun 7, 2022 GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 c... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg M... Microbial Contamination of Non-Sterile Products. Class I Plastikon Healthcare LLC
Jun 7, 2022 GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 ... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged... Microbial Contamination of Non-Sterile Products Class I Plastikon Healthcare LLC
Jun 7, 2022 Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg p... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cup... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg p... Microbial Contamination of Non-Sterile Products. Class I Plastikon Healthcare LLC
Jun 7, 2022 MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged... Microbial Contamination of Non-Sterile Products. Class I Plastikon Healthcare LLC
Jun 7, 2022 Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cup... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg M... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 ... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per ... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 c... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare 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.