Browse Drug Recalls
415 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 415 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 415 FDA drug recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Oct 15, 2015 | Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel c... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Oct 15, 2015 | Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bo... | 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 ... | cGMP Deviations; product does not comply with cGMP requirements | Class II | Sesderma, SL |
| Aug 25, 2015 | Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-... | Lack of Assurance of Sterility: Failed preservative effectiveness testing | Class II | Apotex Inc. |
| Aug 5, 2015 | Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd ... | Failed Impurities/Degradation Specifications: Out of specification results for impurities testing... | Class III | Taro Pharmaceuticals, Inc. |
| Jul 13, 2015 | Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by P... | Subpotent drug | Class III | Perrigo Israel Pharmaceuticals |
| May 29, 2015 | Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured... | Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... | Class II | Apotex Inc. |
| May 29, 2015 | Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufacture... | Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... | Class II | Apotex Inc. |
| May 29, 2015 | Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufacture... | Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... | Class II | Apotex Inc. |
| May 29, 2015 | Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bo... | Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity... | Class II | Apotex Inc. |
| Apr 24, 2015 | Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Ma... | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Class III | Cipla Limited |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 6050... | Subpotent drug | Class III | Apotex Inc. |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 605... | Subpotent drug | Class III | Apotex Inc. |
| Apr 7, 2015 | Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, M... | Subpotent drug | Class III | Apotex 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.