Browse Drug Recalls
3,430 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,430 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 3,430 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 1, 2013 | Lloyd Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.100 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP) , 125 mcg, RX only, 100 tablet... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Levothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Apr 1, 2013 | Lloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-ta... | cGMP deviations; After quality review of stability failures in previous lots, there is insufficie... | Class II | Lloyd Inc. of Iowa |
| Mar 19, 2013 | Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for T... | CGMP Deviation; cotton coil is missing in some packaged bottles | Class III | Teva Pharmaceuticals USA, Inc. |
| Feb 22, 2013 | Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intraveno... | cGMP Deviation | Class II | Petnet Solution Inc |
| Feb 11, 2013 | Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Man... | cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practi... | Class II | Jubilant Cadista Pharmaceuticals Inc. |
| Feb 4, 2013 | Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonat... | CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was no... | Class II | Carib Import & Export, Inc. |
| Jan 30, 2013 | AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor,... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. ... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, ... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, M... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppress... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bo... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl o... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz.... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape F... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, ... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC,... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 ... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bot... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactur... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactur... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongesta... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Ma... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, M... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, ... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufacture... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Man... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufac... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, ... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactu... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant,... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz.... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape F... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, M... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 1... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OT... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuti... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottl... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzale... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, 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.