Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 30, 2020 | Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 ... | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... | Class II | Albek De Mexico S.A. De C.V. |
| Jul 30, 2020 | Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol ... | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... | Class II | Albek De Mexico S.A. De C.V. |
| Jul 30, 2020 | NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcoho... | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... | Class II | Albek De Mexico S.A. De C.V. |
| Jul 30, 2020 | NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ... | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... | Class II | Albek De Mexico S.A. De C.V. |
| Jul 30, 2020 | Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 ... | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... | Class II | Albek De Mexico S.A. De C.V. |
| Jul 30, 2020 | Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab I... | Discoloration and Presence of Foreign Substance | Class II | Ecolab Inc |
| Jul 29, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... | Class I | SCA Pharmaceuticals |
| Jul 29, 2020 | Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Cont... | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... | Class I | SCA Pharmaceuticals |
| Jul 29, 2020 | Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... | Class I | SCA Pharmaceuticals |
| Jul 29, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... | Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. | Class II | SCA Pharmaceuticals |
| Jul 29, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Conta... | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... | Class I | SCA Pharmaceuticals |
| Jul 27, 2020 | Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Al... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC ... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.... | cGMP deviations | Class II | RESOURCE RECOVERY & TRADING LLC |
| Jul 27, 2020 | Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-041... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Cal... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & ... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & C... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as ... | Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below ... | Class I | Broncolin, S.A. de C.V. |
| Jul 27, 2020 | Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (20... | cGMP deviations | Class II | RESOURCE RECOVERY & TRADING LLC |
| Jul 27, 2020 | HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as ... | CGMP Deviations: products were recalled because they were manufactured in the same facility as th... | Class II | Broncolin, S.A. de C.V. |
| Jul 27, 2020 | Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Cal... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distribut... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin ... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distrib... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., ... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distri... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distri... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count ... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distrib... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 27, 2020 | Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calv... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Jul 24, 2020 | VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosp... | cGMP deviations | Class II | Vilvet Pharmaceuticals Inc. |
| Jul 24, 2020 | Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-9... | Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ... | Class III | Golden State Medical Supply Inc. |
| Jul 24, 2020 | VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate ... | cGMP deviations | Class II | Vilvet Pharmaceuticals Inc. |
| Jul 23, 2020 | scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcoh... | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content an... | Class II | Real Clean Distribuciones SA de CV |
| Jul 23, 2020 | BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 ... | Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol con... | Class I | Real Clean Distribuciones SA de CV |
| Jul 23, 2020 | LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, ... | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content an... | Class II | Real Clean Distribuciones SA de CV |
| Jul 23, 2020 | BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packa... | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content an... | Class II | Real Clean Distribuciones SA de CV |
| Jul 23, 2020 | scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL... | CGMP Deviations: Other products were recalled because they were manufactured in the same facility... | Class II | Real Clean Distribuciones SA de CV |
| Jul 22, 2020 | Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr.... | Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code. | Class III | West-Ward Columbus Inc |
| Jul 22, 2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 m... | Cross Contamination with other products: trace amounts of lidocaine | Class I | Fresenius Kabi USA, LLC |
| Jul 21, 2020 | STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with s... | Superpotent Drug | Class I | Ferring Pharmaceuticals Inc |
| Jul 21, 2020 | Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap... | Superpotent Drug | Class I | Ferring Pharmaceuticals Inc |
| Jul 21, 2020 | DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only... | Superpotent Drug | Class I | Ferring Pharmaceuticals Inc |
| Jul 21, 2020 | Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrou... | Failed Impurities/Degradation Specifications: Out of specification result observed in related sub... | Class II | Lupin Pharmaceuticals Inc. |
| Jul 20, 2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L)... | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Class I | Liq-E S.A. De C.V. |
| Jul 20, 2020 | Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose... | Lack of Assurance of Sterility; potential loose metal overseal crimp defects. | Class II | Pfizer 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.