fda
62 records
FDA Drug Recall: Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only,
2026-03-04
Class II — Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
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FDA Drug Recall: Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per car
2026-01-14
Class II — Out of specification for dissolution.
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FDA Drug Recall: Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.02
2025-10-15
Class II — Failed Content Uniformity Specifications
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FDA Drug Recall: chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose c
2025-09-17
Class II — Presence of a foreign substance.
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FDA Drug Recall: chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose
2025-09-17
Class II — Presence of a foreign substance.
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FDA Drug Recall: Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: Av
2025-07-09
Class III — Failed Impurity/Degradation Specifications
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FDA Drug Recall: Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: Av
2025-07-09
Class III — Failed Impurity/Degradation Specifications
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FDA Drug Recall: Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton
2025-06-18
Class II — Failed Dissolution Specifications
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FDA Drug Recall: Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Ma
2025-06-18
Class II — Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
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FDA Drug Recall: Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pul
2025-02-26
Class II — Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
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FDA Drug Recall: Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufa
2025-02-19
Class II — Out of Specification for Dissolution
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FDA Drug Recall: Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Ey
2025-01-08
Class III — LABELING: LABEL MIX-UP
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FDA Drug Recall: Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton,
2025-01-08
Class II — Failed Dissolution Specifications
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FDA Drug Recall: Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.
2025-01-08
Class III — LABELING: LABEL MIX-UP
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FDA Drug Recall: Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for:
2024-12-11
Class II — Labeling: Label Mix-Up
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FDA Drug Recall: Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, P
2024-12-11
Class II — CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
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FDA Drug Recall: Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, P
2024-12-11
Class II — CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
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FDA Drug Recall: Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, P
2024-12-11
Class II — CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
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FDA Drug Recall: Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: A
2024-12-11
Class II — Labeling: Label Mix-Up
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FDA Drug Recall: Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons
2024-04-24
Class I — Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
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FDA Drug Recall: Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET W
2023-09-13
Class II — Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
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FDA Drug Recall: Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm F
2023-09-13
Class II — Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription D...
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FDA Drug Recall: Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manuf
2023-06-21
Class III — Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
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FDA Drug Recall: Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only,
2023-01-04
Class II — Failed impurities/degradation specifications: Out of specification for unknown impurities.
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FDA Drug Recall: Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for:
2022-08-17
Class III — Labeling: Label Error on Declared Strength
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FDA Drug Recall: Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured fo
2021-06-23
Class III — Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
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FDA Drug Recall: TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufact
2020-12-23
Class I — Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
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FDA Drug Recall: Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKA
2020-12-23
Class II — Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
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FDA Drug Recall: Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottl
2020-11-18
Class II — Failed Dissolution Specifications
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FDA Drug Recall: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 5
2020-06-24
Class II — CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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FDA Drug Recall: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42
2020-06-24
Class II — CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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FDA Drug Recall: Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60,
2020-06-10
Class III — Presence of Foreign Substance consistent with granules from desiccant packs used during storage
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FDA Drug Recall: Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only,
2020-01-22
Class II — Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
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FDA Drug Recall: AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pul
2019-12-04
Class II — CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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FDA Drug Recall: AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc.
2019-12-04
Class II — CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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FDA Drug Recall: AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-7
2019-11-06
Class II — CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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FDA Drug Recall: AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-7
2019-11-06
Class II — CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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FDA Drug Recall: AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets
2019-09-18
Class II — Failed Stability Specifications.
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FDA Drug Recall: Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 502
2019-05-08
Class II — CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per mill...
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FDA Drug Recall: Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 502
2019-05-08
Class II — CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per mill...
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FDA Drug Recall: Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufacture
2019-04-17
Class III — Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
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FDA Drug Recall: Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablet
2019-03-27
Class II — CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
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FDA Drug Recall: Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only,
2019-03-27
Class II — CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
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FDA Drug Recall: Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets
2019-03-27
Class II — CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
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FDA Drug Recall: Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 4229
2019-03-20
Class III — Failed Dissolution Specifications
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FDA Drug Recall: Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222
2018-12-05
Class II — Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
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FDA Drug Recall: AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle
2018-09-12
Class II — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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FDA Drug Recall: AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle,
2018-09-12
Class II — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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FDA Drug Recall: AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle
2018-09-12
Class II — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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FDA Drug Recall: AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle,
2018-09-12
Class II — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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FDA Drug Recall: AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, R
2018-09-12
Class II — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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FDA Drug Recall: Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dos
2018-09-05
Class II — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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FDA Drug Recall: Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-
2018-09-05
Class II — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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FDA Drug Recall: Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-1
2018-09-05
Class II — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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FDA Drug Recall: Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-1
2018-09-05
Class II — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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FDA Drug Recall: Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Ma
2018-04-25
Class II — Failed Dissolution Specifications
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FDA Drug Recall: Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manu
2018-01-24
Class II — Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
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FDA Drug Recall: Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose p
2017-11-08
Class II — Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
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FDA Drug Recall: Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manuf
2017-08-23
Class III — Failed impurities/degradation specifications: Out of specification for a related compound C.
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FDA Drug Recall: Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Ma
2017-03-29
Class II — Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
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FDA Drug Recall: Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manuf
2015-03-11
Class III — Subpotent Drug
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FDA Drug Recall: Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufa
2015-03-11
Class III — Subpotent Drug
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fda_adverse
1 records
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