Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tabl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only M... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only M... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Ta... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Ta... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 13, 2018 | Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tab... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Prinston Pharmaceutical Inc |
| Jul 3, 2018 | Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application... | CGMP Deviations: The manufacturer of this product recalled because they were not manufactured und... | Class II | Medgyn Products, Inc. |
| Jul 3, 2018 | Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL),... | CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a... | Class II | Medi-Fare Drug and Home Health Center |
| Jun 22, 2018 | Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by ... | CGMP Deviations | Class II | Akorn, Inc. |
| Jun 11, 2018 | Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | BioDiagnostic International |
| May 25, 2018 | X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC... | CGMP Deviations: products may be contaminated with bacteria. | Class II | Shadow Holdings DBA Bocchi Labs |
| May 25, 2018 | Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic aci... | CGMP Deviations: products may be contaminated with bacteria. | Class II | Shadow Holdings DBA Bocchi Labs |
| May 25, 2018 | Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) t... | CGMP Deviations: products may be contaminated with bacteria. | Class II | Shadow Holdings DBA Bocchi Labs |
| May 25, 2018 | Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL)... | CGMP Deviations: products may be contaminated with bacteria. | Class II | Shadow Holdings DBA Bocchi Labs |
| May 16, 2018 | screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g... | CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed ... | Class II | Ideaz Llc |
| May 16, 2018 | screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g)... | CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed ... | Class II | Ideaz Llc |
| May 7, 2018 | Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| May 7, 2018 | Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Mag... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| May 7, 2018 | RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. O... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| May 7, 2018 | Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged i... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| May 7, 2018 | RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| May 7, 2018 | Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz.... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| May 7, 2018 | RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottle... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| May 7, 2018 | Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxid... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| May 7, 2018 | GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by ... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| May 7, 2018 | Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, G... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| 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 |
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.