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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 861–880 of 1,000 recalls

Class IIITerminated

Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01

GSK Consumer Healthcare

Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".

October 18, 2016 · DrugView details →
Class IIITerminated

HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459

Town and Country Compounding and Consultation Services, LLC

Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).

October 18, 2016 · Drug
View details →
Class IIITerminated

AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217

Amerisource Health Services

Presence of Foreign Tablets/Capsules

October 13, 2016 · DrugView details →
Class IIITerminated

Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30

Dr. Reddy's Laboratories, Inc.

Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.

October 13, 2016 · DrugView details →
Class IIITerminated

HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20

Pharm D Solutions, LLC

Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct

October 12, 2016 · DrugView details →
Class IIITerminated

Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04

Pharm D Solutions, LLC

Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct

October 12, 2016 · DrugView details →
Class IIITerminated

NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10

Actavis Elizabeth LLC

Presence of Foreign Tablets/Capsules

October 6, 2016 · DrugView details →
Class IIITerminated

Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.

Amerisource Health Services

Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.

September 30, 2016 · DrugView details →
Class IIITerminated

Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20

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 16 month timepoint.

September 28, 2016 · DrugView details →
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 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 IIITerminated

Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →
Class IIITerminated

Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →
Class IIITerminated

Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →
Class IIITerminated

Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →
Class IIITerminated

Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10

Mckesson Packaging Services

Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).

September 15, 2016 · DrugView details →
Class IIITerminated

PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91

Pfizer Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.

September 15, 2016 · DrugView details →
Class IIITerminated

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86

Sun Pharmaceutical Industries, Inc.

Failed Dissolution Specifications

September 13, 2016 · DrugView details →
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