Browse Drug Recalls

399 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 399 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 399 FDA drug recalls in N/A.

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DateProductReasonClassFirm
Mar 4, 2019 ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 ... Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contain... Class III Petra Hygienic Systems Int Ltd
Mar 1, 2019 Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Bli... Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. Class II Apotex Inc.
Jan 11, 2019 Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufact... Defective Container; complaints of leakage. Class III Oxalis Labs
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, M... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manuf... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bott... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Ma... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, M... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottl... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manu... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, M... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manuf... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manu... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bott... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Dec 4, 2018 Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Mylan Laboratories Limited, (Nashik FDF)
Oct 24, 2018 Irbesartan Bulk Active Pharmaceutical Ingredient. CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... Class II Aurobindo Pharma Limited (Unit I)
Jul 18, 2018 Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured f... Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted... Class II Hetero Labs, Ltd. - Unit III
Jul 17, 2018 Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (ND... CGMP Deviations Class II Longbow First Aid Products Manufactory
Jul 17, 2018 Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (... CGMP Deviations Class II Longbow First Aid Products Manufactory
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.

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.