Browse Drug Recalls

1,018 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,018 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 1,018 FDA drug recalls in NY.

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Date	Product	Reason	Class	Firm
May 29, 2020	amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 9...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 ta...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distribut...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, ...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tabl...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only ...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 29, 2020	amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only...	CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl...	Class II	Amneal Pharmaceuticals of New York, LLC
May 27, 2020	Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 ...	Failed Dissolution Specifications	Class III	Pfizer Inc.
May 14, 2020	Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: ...	Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-ter...	Class III	InvaGen Pharmaceuticals, Inc.
Apr 15, 2020	Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Di...	CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the ...	Class II	Amneal Pharmaceuticals of New York, LLC
Apr 14, 2020	Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Com...	Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain m...	Class I	MasterPharm LLC
Mar 30, 2020	Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Ph...	Failed Impurities/Degradation Specification: Presence of unknown impurity observed.	Class II	Par Pharmaceutical Inc.
Mar 4, 2020	PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par...	Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Pre...	Class III	Par Pharmaceutical Inc.
Feb 27, 2020	Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distri...	Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The...	Class II	Pfizer Inc.
Feb 10, 2020	Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablet...	Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiratio...	Class III	Par Pharmaceutical Inc.
Feb 7, 2020	Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only...	Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may ...	Class I	Taro Pharmaceuticals U.S.A., Inc.
Feb 5, 2020	Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-c...	Defective Container: products potentially could have been packaged in defective bottles, with a n...	Class II	Pfizer Inc.
Feb 5, 2020	Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-c...	Defective Container: products potentially could have been packaged in defective bottles, with a n...	Class II	Pfizer Inc.
Feb 3, 2020	Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dos...	Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects...	Class II	Pfizer Inc.
Feb 3, 2020	Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reduc...	Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement...	Class II	Contract Pharmacal Corporation
Feb 3, 2020	Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reduce...	Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement...	Class II	Contract Pharmacal Corporation
Dec 20, 2019	Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 9...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Denton Pharma, Inc.
Dec 20, 2019	Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 2...	CGMP Deviations: Presence of NDMA impurity detected in product.	Class II	Denton Pharma, Inc.
Dec 20, 2019	Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro P...	Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.	Class I	Taro Pharmaceuticals U.S.A., Inc.
Nov 27, 2019	25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only,...	Labeling: Incorrect or Missing Lot and/or expiration date.	Class II	Pfizer Inc.
Nov 25, 2019	Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Pa...	Failed Impurities/Degradation Specifications	Class II	Medisca, Inc.
Nov 25, 2019	VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 ...	Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the pro...	Class III	Apothecus Pharmaceutical Corp.
Nov 22, 2019	Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Class II	Amneal Pharmaceuticals, Inc.
Nov 22, 2019	Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Class II	Amneal Pharmaceuticals, Inc.
Nov 22, 2019	Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).1...	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Class II	Amneal Pharmaceuticals, Inc.
Nov 22, 2019	Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Class II	Amneal Pharmaceuticals, Inc.
Nov 22, 2019	Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).1...	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	Class II	Amneal Pharmaceuticals, Inc.
Oct 16, 2019	Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10...	Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.	Class III	Amneal Pharmaceuticals, Inc.
Oct 11, 2019	Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manuf...	Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.	Class III	X-Gen Pharmaceuticals Inc.
Oct 2, 2019	10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 ...	Lack of Assurance of Sterility: Bag has the potential to leak.	Class II	Pfizer Inc.
Sep 27, 2019	Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-...	Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019	Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-...	Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019	Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Man...	Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019	Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-...	Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019	Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manu...	Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert...	Class II	Taro Pharmaceuticals U.S.A., Inc.
Sep 26, 2019	Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic P...	Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol...	Class II	Epic Pharma, LLC
Sep 24, 2019	Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by...	Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle	Class III	Amneal Pharmaceuticals, Inc.
Sep 12, 2019	ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by...	Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco...	Class III	Pfizer Inc.
Sep 12, 2019	Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made...	Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco...	Class III	Pfizer Inc.
Sep 6, 2019	Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hosp...	Lack of Assurance of Sterility	Class II	Pfizer Inc.
Aug 14, 2019	RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 ta...	Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.	Class II	Pfizer Inc.
Jul 26, 2019	Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each displa...	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s...	Class II	Medtech Products, Inc.
Jul 26, 2019	Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochlorid...	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s...	Class II	Medtech Products, Inc.
Jul 26, 2019	Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 7...	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s...	Class II	Medtech Products, 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.