Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 19, 2019 | Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bott... | Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg ... | Class II | Lupin Pharmaceuticals Inc. |
| Jul 19, 2019 | MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as o... | Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed micro... | Class II | Dercher Enterprises, Inc., DBA Gordon Laboratories |
| Jul 19, 2019 | Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b)... | Failed Dissolution Specifications | Class II | Ascend Laboratories LLC |
| Jul 18, 2019 | Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manu... | Failed Dissolution Specifications. | Class II | Ucb, Inc |
| Jul 18, 2019 | 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter... | Lack of Assurance of Sterility: Bags have potential to leak. | Class II | Baxter Healthcare Corporation |
| Jul 18, 2019 | Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg ... | CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufactur... | Class II | Preferred Pharmaceuticals, Inc |
| Jul 17, 2019 | Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, pack... | Subpotent Drug | Class II | ImprimisRx NJ |
| Jul 17, 2019 | Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 333... | Failed Dissolution Specifications | Class II | Macleods Pharma Usa Inc |
| Jul 17, 2019 | Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottle... | Subpotent Drug | Class II | ImprimisRx NJ |
| Jul 17, 2019 | Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bot... | Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on... | Class II | Lupin Pharmaceuticals Inc. |
| Jul 16, 2019 | Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-0... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07)... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-0... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-0... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: ... | Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enume... | Class II | Bionpharma Inc. |
| Jul 15, 2019 | LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, ... | Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling o... | Class II | La Fresh Group, Inc. |
| Jul 15, 2019 | DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistami... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Jul 15, 2019 | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Jul 15, 2019 | CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moi... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Jul 12, 2019 | Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Edema Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Fungo Off Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Lung Tonic EX Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Detensin, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Smoke End Capsules,Distributed Herbal Doctor Remedies Alhambra, CA 91801-7081... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Stomach Flu Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 9180... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Herpes-V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Worm Off, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Dragon Pain Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-708... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Herpes-S, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Baby Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Asma Stopper Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Anemia Off, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 US... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Lung Fixer Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Herpes-G Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Hair Back, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Asthma Balm 60 gram, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Yeast Douche Powder, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Psoriasis Balm, 60 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, ... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Vertigo Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 9180... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Lube Lax Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Sperm Booster, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Asma Aid Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Cardia Forte, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alham... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Lung Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Dragon Pain Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-70... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Fungo Balm, 30 gram, Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(80... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Deafness Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 918... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
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.