Browse Drug Recalls

989 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 989 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 989 FDA drug recalls in TN.

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DateProductReasonClassFirm
Feb 13, 2026 Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Onl... Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification ... Class II AvKARE
Dec 31, 2025 Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per ... Out of specification for dissolution. Class II AvKARE
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...
Sep 2, 2025 Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0... Failed Content Uniformity Specifications Class II AvKARE
Aug 25, 2025 chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit do... Presence of a foreign substance. Class II AvKARE
Aug 25, 2025 chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dos... Presence of a foreign substance. Class II AvKARE
Aug 25, 2025 Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By T... Cross Contamination with Other Products. Class III Consumer Product Partners, LLC
Aug 25, 2025 TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distribu... Cross Contamination with Other Products. Class III Consumer Product Partners, LLC
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...
Aug 6, 2025 Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured ... CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable... Class II Westminster Pharmaceuticals LLC
Aug 6, 2025 Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured... CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable... Class II Westminster Pharmaceuticals LLC
Jun 26, 2025 Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... Failed Impurity/Degradation Specifications Class III AvKARE
Jun 26, 2025 Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... Failed Impurity/Degradation Specifications Class III AvKARE
May 23, 2025 Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per... Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl... Class II Consumer Product Partners, LLC
May 13, 2025 Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only,... Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was ... Class II AvKARE
May 9, 2025 Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per car... Failed Dissolution Specifications Class II AvKARE
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 26, 2025 Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsul... CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-de... Class II Chattem Inc
Mar 7, 2025 [CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT... Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol Class II Consumer Product Partners, LLC
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...
Mar 4, 2025 Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, ... CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable int... Class II Chattem Inc
Feb 4, 2025 Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, ... Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stabili... Class II AvKARE
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 24, 2025 HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only... Failed Impurities/Degradation Specifications Class II SKY PACKAGING
Jan 24, 2025 HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactu... Failed Impurities/Degradation Specifications Class II SKY PACKAGING
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 Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Man... Out of Specification for Dissolution Class II AvKARE
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...
Dec 18, 2024 Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops,... LABELING: LABEL MIX-UP Class III AvKARE
Dec 18, 2024 Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant... LABELING: LABEL MIX-UP Class III AvKARE
Dec 4, 2024 Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per cart... Failed Dissolution Specifications Class II AvKARE
Nov 27, 2024 Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE... CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinac... Class II AvKARE
Nov 27, 2024 Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE... CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinac... Class II AvKARE
Nov 27, 2024 Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE... CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinac... Class II AvKARE
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 6, 2024 MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallo... cGMP Deviations: Out of specification results for micro in hand soap products. Class II Midlab Incorporated
Nov 6, 2024 Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L),... cGMP Deviations: Out of specification results for micro in hand soap products. Class II Midlab Incorporated
Nov 6, 2024 Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: ... cGMP Deviations: Out of specification results for micro in hand soap products. Class II Midlab Incorporated
Nov 6, 2024 boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L),... cGMP Deviations: Out of specification results for micro in hand soap products. Class II Midlab Incorporated
Nov 6, 2024 Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ... cGMP Deviations: Out of specification results for micro in hand soap products. Class II Midlab Incorporated
Nov 6, 2024 ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ... cGMP Deviations: Out of specification results for micro in hand soap products. Class II Midlab Incorporated

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.