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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.