Browse Drug Recalls

695 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 695 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 695 FDA drug recalls in PA.

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Date	Product	Reason	Class	Firm
May 15, 2013	Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysat...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution wi...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysat...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - di...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution wi...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysat...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dial...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialys...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
May 15, 2013	Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino aci...	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri...	Class II	Pentec Health
Apr 26, 2013	Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0...	Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin p...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 19, 2013	Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for T...	CGMP Deviation; cotton coil is missing in some packaged bottles	Class III	Teva Pharmaceuticals USA, Inc.
Mar 15, 2013	Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 m...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 15, 2013	Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 9...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 15, 2013	Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 ...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 15, 2013	Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 15, 2013	Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 15, 2013	Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 t...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 14, 2013	Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and E...	Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 14, 2013	Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 e...	Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 12, 2013	Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, ...	Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specifica...	Class III	Teva Pharmaceuticals USA, Inc.
Mar 12, 2013	Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count...	Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specifica...	Class III	Teva Pharmaceuticals USA, Inc.
Feb 27, 2013	Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mu...	Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ...	Class III	Mutual Pharmaceutical Company, Inc.
Feb 27, 2013	FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102...	Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ...	Class III	Mutual Pharmaceutical Company, Inc.
Feb 27, 2013	Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 5...	Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ...	Class III	Mutual Pharmaceutical Company, Inc.
Feb 26, 2013	Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0...	Defective Container: This recall is being carried out due to the potential for improperly sealed ...	Class II	Teva Pharmaceuticals USA, Inc.
Feb 7, 2013	CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blist...	Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specificat...	Class II	Teva Pharmaceuticals USA, Inc.
Jan 23, 2013	Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC...	Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in...	Class II	Teva Pharmaceuticals USA, Inc.
Jan 4, 2013	Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA,...	Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingre...	Class I	Reumofan Plus USA
Dec 5, 2012	Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single us...	Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of p...	Class II	Teva Pharmaceuticals USA, Inc.
Dec 4, 2012	Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx on...	Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolut...	Class II	Amedra Pharmaceuticals LLC
Dec 4, 2012	Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx on...	Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolut...	Class II	Amedra Pharmaceuticals LLC
Dec 4, 2012	Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx on...	Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolut...	Class II	Amedra Pharmaceuticals LLC
Oct 22, 2012	Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bot...	Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the...	Class I	Zi Xiu Tang Success, LLC
Oct 22, 2012	Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi...	Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the...	Class I	Zi Xiu Tang Success, LLC
Aug 17, 2012	Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by...	Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide...	Class III	Axcentria Pharmaceuticals LLC
Jul 12, 2012	Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 m...	Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packagi...	Class III	Axcentria Pharmaceuticals LLC
May 18, 2012	Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed b...	Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particl...	Class II	Teva Pharmaceuticals USA, Inc.
May 17, 2012	Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg,...	Defective Container; damaged blister units	Class III	Mcneil Consumer Healthcare, Div Of Mcneil-ppc, ...
May 16, 2012	Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactur...	Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and o...	Class II	Teva Pharmaceuticals USA, Inc.
May 7, 2012	Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count t...	Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablet...	Class III	Endo Pharmaceuticals, Inc.
May 2, 2012	Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0....	Impurities/Degradation: This recall is being carried out due to the potential for some lots not ...	Class II	Teva Pharmaceuticals USA, Inc.
Apr 24, 2012	CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA...	Impurities/Degradation Products: This lot of product will not meet the impurity specification ove...	Class III	Teva Pharmaceuticals USA, Inc.
Apr 23, 2012	Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each...	Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that s...	Class III	Teva Pharmaceuticals USA, Inc.
Apr 10, 2012	Carbon Dioxide, USP, Medical Gas, packaged in a) size EA aluminum, CGA940 (CD...	Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide.	Class II	Airgas Inc
Apr 2, 2012	Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs p...	Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.	Class II	Teva Pharmaceuticals USA, 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.