Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jan 30, 2013 | BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, I... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Dis... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle,... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle,... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 30, 2013 | Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufac... | CGMP Deviations: Products are underdosed or have an incorrect dosage regime. | Class II | TG United, Inc. |
| Jan 22, 2013 | Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg... | CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturin... | Class II | RX South LLC DBA RX3 Pharmacy |
| Nov 2, 2012 | ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, ... | CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not se... | Class II | Bristol Myers Squibb Manufacturing Company |
| Sep 28, 2012 | Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%)... | CGMP Deviations: The products were manufactured with raw material which contain unknown particles... | Class III | ITW Dymon |
| Sep 6, 2012 | Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, ... | CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substitu... | Class II | Church & Dwight Inc |
| Jul 9, 2012 | Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, ... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, ... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, ... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
| Jul 9, 2012 | Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, R... | cGMP Deviations; does not meet in process specification requirements | Class II | Lloyd Inc. of Iowa |
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.