Browse Drug Recalls

3,430 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,430 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 3,430 FDA drug recalls.

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DateProductReasonClassFirm
May 7, 2018 SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, D... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL ... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 1, 2018 Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Ma... GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 1, 2018 Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Ma... GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Apr 30, 2018 PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, ... CGMP Deviations Class II Mylan Pharmaceuticals Inc.
Apr 30, 2018 PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 4... CGMP Deviations Class II Mylan Pharmaceuticals Inc.
Apr 30, 2018 PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only,... CGMP Deviations Class II Mylan Pharmaceuticals Inc.
Apr 24, 2018 Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, M... cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was n... Class II Mylan Pharmaceuticals Inc.
Apr 24, 2018 Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, M... cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not... Class II Mylan Pharmaceuticals Inc.
Apr 24, 2018 Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01 CGMP Deviations Class II Mylan Pharmaceuticals Inc.
Apr 24, 2018 Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01 CGMP Deviations Class II Mylan Pharmaceuticals Inc.
Apr 10, 2018 Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 ... cGMP deviations Class III Pharmedium Services, LLC
Apr 2, 2018 WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dis... CGMP Deviations: finished products were manufactured with poor quality water. Class II Diamond Wipes International, Inc.
Apr 2, 2018 ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30... CGMP Deviations: finished products were manufactured with poor quality water. Class II Diamond Wipes International, Inc.
Mar 29, 2018 Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC ... CGMP Deviations: the product was produced with substandard GMP manufacturing processes. Class II United Pacific Co Ltd
Mar 28, 2018 Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), El... cGMP Deviations Class II Elroselabs Inc.
Mar 28, 2018 Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc. cGMP Deviations Class II Elroselabs Inc.
Mar 28, 2018 Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, M... cGMP Deviations Class II Elroselabs Inc.
Feb 19, 2018 Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufact... cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II Kalchem International, Inc.
Feb 9, 2018 Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-80... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 2... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Testosterone Cypionate USP (Micronized) for prescription compounding, packag... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (N... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g ... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a)... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 5859... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 5... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, pa... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (ND... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 585... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 5859... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 5859... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (N... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g ... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 50... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (ND... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-803... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, p... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a)... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-85... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed ... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 5... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC

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.