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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 11121–11140 of 17,816 recalls

Class IIITerminated

Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.

September 28, 2016 · DrugView details →
Class IITerminated

Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue

North American Rescue LLC.

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

September 27, 2016 · DrugView details →
Class IITerminated

Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue

North American Rescue LLC.

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

September 27, 2016 · DrugView details →
Class IITerminated

Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue

North American Rescue LLC.

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

September 27, 2016 · DrugView details →
Class IITerminated

USCG Boat Response Kit - Product Code 80-0353, North American Rescue

North American Rescue LLC.

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

September 27, 2016 · DrugView details →
Class IITerminated

Aid Backpack Kit - Product Code 85-0917, North American Rescue

North American Rescue LLC.

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

September 27, 2016 · DrugView details →
Class IIICompleted

Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Par Pharmaceutical, Inc.

Subpotent Drug; Ethinyl Estradiol

September 27, 2016 · DrugView details →
Class IITerminated

Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue

North American Rescue LLC.

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

September 27, 2016 · DrugView details →
Class IIICompleted

Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Par Pharmaceutical, Inc.

Subpotent Drug; Ethinyl Estradiol

September 27, 2016 · DrugView details →
Class IITerminated

K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue

North American Rescue LLC.

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

September 27, 2016 · DrugView details →
Class IITerminated

Range Trauma Kit - Product Code 85-1274, North American Rescue

North American Rescue LLC.

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

September 27, 2016 · DrugView details →
Class IIICompleted

Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Par Pharmaceutical, Inc.

Subpotent Drug; Ethinyl Estradiol

September 27, 2016 · DrugView details →
Class IITerminated

Amphibious Trauma Kit - Product Code 85-0639, North American Rescue

North American Rescue LLC.

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

September 27, 2016 · DrugView details →
Class IIICompleted

Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Par Pharmaceutical, Inc.

Subpotent Drug; Ethinyl Estradiol

September 27, 2016 · DrugView details →
Class IIICompleted

Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Par Pharmaceutical, Inc.

Subpotent Drug; Ethinyl Estradiol

September 27, 2016 · DrugView details →
Class ITerminated

Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only

Guardian Pharmacy Services

Non-Sterility: failed sterility test result.

September 23, 2016 · DrugView details →
Class IIITerminated

PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

September 22, 2016 · DrugView details →
Class IIITerminated

PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

September 22, 2016 · DrugView details →
Class IIITerminated

PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.

September 22, 2016 · DrugView details →
Class IITerminated

Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL

Wells Pharmacy Network LLC

Lack of Assurance of Sterility

September 21, 2016 · DrugView details →
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