Browse Drug Recalls
379 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 379 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 379 FDA drug recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 31, 2018 | Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray... | Presence of foreign substance: glass particles | Class II | Apotex Inc. |
| Jan 10, 2018 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured fo... | CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... | Class II | Hetero Labs, Ltd. - Unit III |
| Jan 2, 2018 | Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for in... | Presence of Particulate Matter: A confirmed customer report was received for the presence of visi... | Class I | Aurobindo Pharma Ltd. |
| Dec 22, 2017 | Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for... | Presence of foreign substance: metallic razor blade was found in one bottle. | Class III | Hetero Labs, Ltd. - Unit III |
| Dec 20, 2017 | Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. ... | Failed Stability Specifications:stability failure at 12 months, long term RT conditions. | Class II | Odan Laboratories Ltd |
| Dec 20, 2017 | Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxyben... | Failed Stability Specifications:stability failure at 12 months, long term RT conditions. | Class II | Odan Laboratories Ltd |
| Nov 17, 2017 | Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufacture... | Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy compla... | Class II | Lupin Limited |
| Oct 12, 2017 | Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) ... | Presence of foreign substance (screw) | Class II | Hetero Labs, Ltd. - Unit III |
| Sep 27, 2017 | FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bu... | Microbial Contamination of Non-Sterile Products | Class II | Pfizer Manufacturing Deutschland GmbH |
| Aug 4, 2017 | Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Ma... | Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% ... | Class II | Degasa Sa De Cv |
| Jul 17, 2017 | Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net W... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt.... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methox... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Ne... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt.... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net ... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| Jul 17, 2017 | Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxyci... | Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 1... | Class III | Linde Eckstein Gmbh + Co KG |
| May 16, 2017 | Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewa... | Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last... | Class I | Lupin Limited (Unit 1) |
| Mar 24, 2017 | Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compoundi... | cGMP Deviations; lack of quality assurance. | Class II | Qinhuangdao Zizhu Pharmaceutical, Co. |
| Mar 24, 2017 | Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compoundin... | cGMP Deviations; lack of quality assurance. | Class II | Qinhuangdao Zizhu Pharmaceutical, Co. |
| Mar 24, 2017 | Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, M... | cGMP Deviations; lack of quality assurance. | Class II | Qinhuangdao Zizhu Pharmaceutical, Co. |
| Mar 24, 2017 | Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufac... | cGMP Deviations; lack of quality assurance. | Class II | Qinhuangdao Zizhu Pharmaceutical, Co. |
| Mar 24, 2017 | Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufacture... | cGMP Deviations; lack of quality assurance. | Class II | Qinhuangdao Zizhu Pharmaceutical, Co. |
| Mar 24, 2017 | Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufac... | cGMP Deviations; lack of quality assurance. | Class II | Qinhuangdao Zizhu Pharmaceutical, Co. |
| Mar 24, 2017 | Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufac... | cGMP Deviations; lack of quality assurance. | Class II | Qinhuangdao Zizhu Pharmaceutical, Co. |
| Feb 3, 2017 | CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by... | Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown I... | Class II | Apotex Inc. |
| Dec 29, 2016 | Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : ... | Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of p... | Class III | Hetero Drugs Ltd. - Unit 1 |
| Dec 19, 2016 | Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex... | Superpotent Drug: Product may not meet specifications throughout shelf life. | Class III | Apotex Inc. |
| Nov 22, 2016 | Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed... | Labeling: Label Mix Up- Incorrect back label applied to the product. | Class III | Les Emballages Knowlton Inc. |
| Oct 19, 2016 | Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Man... | Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial ... | Class II | Inventia Healthcare Private Limited |
| Sep 7, 2016 | Varithena (polidocanol injectable foam) Administration Pack For Use With Vari... | Defective Delivery System: Incorrect type of syringe found in commercially distributed administra... | Class III | Biocompatibles U.K., Ltd. |
| May 18, 2016 | Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compoun... | cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration | Class III | Attix Pharmaceuticals Inc |
| Mar 11, 2016 | SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by J... | Labeling: Label Error on Declared Strength | Class III | Jubilant Draximage Inc |
| Feb 25, 2016 | Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per car... | Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as... | Class III | Torrent Pharmaceuticals Limited |
| Feb 11, 2016 | Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only... | Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceedi... | Class II | Sun Pharma Global Fze |
| Oct 20, 2015 | Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bott... | Labeling: Incorrect or Missing Lot AND/OR Exp Date. | Class III | Teva Pharmaceutical Industries |
| Oct 15, 2015 | Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL)... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avob... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 5... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avob... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, B... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bo... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
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.