FDA Recalls USDA Recalls About

FDA Recalls

Food recalls
Drug recalls
Device recalls

USDA Recalls

All USDA recalls
Poultry recalls
Meat recalls
Egg recalls

About

About us
FDA guides
USDA guides
Data sources
Privacy policy

Data

OpenFDA API
USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

FDA Recalls
›Drug Recalls

FDA Drug Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 6241–6260 of 17,773 recalls

Class IITerminated

Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0625-1

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Lack of Assurance of Sterility

January 15, 2020 · DrugView details →

Class IITerminated

Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0331-3

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Lack of Assurance of Sterility

January 15, 2020 · DrugView details →

Class IITerminated

Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0306-1

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Lack of Assurance of Sterility

January 15, 2020 · DrugView details →

Class IITerminated

Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534

Direct Rx

CGMP Deviations: Presence of NDMA impurity detected in product.

January 15, 2020 · DrugView details →

Class IITerminated

Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16

Pharmaceutical Associates Inc

Subpotent: Out of specification for assay at the 12-month time point.

January 14, 2020 · DrugView details →

Class IITerminated

Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India

Sun Pharmaceutical Industries, Inc.

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

January 14, 2020 · DrugView details →

Class IIITerminated

methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.

Hikma Pharmaceuticals USA Inc.

Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.

January 14, 2020 · DrugView details →

Class IITerminated

Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram

Spectrum Laboratory Products

CGMP Deviations: Presence of NDMA impurity detected in product.

January 14, 2020 · DrugView details →

Class IITerminated

Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India

Sun Pharmaceutical Industries, Inc.

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

January 14, 2020 · DrugView details →

Class IITerminated

Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) 500 gm NDC 62991-2159-05; f) 5 gm NDC 62991-2159-02, Rx Only Repackaged by: Letco Medical, LLC. Decatur, AL 35601

Letco Medical LLC

Subpotent

January 10, 2020 · DrugView details →

Class IIITerminated

Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)

Lupin Pharmaceuticals Inc.

CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.

January 10, 2020 · DrugView details →

Class IITerminated

NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.

Advanced Accelerator Applications USA, Inc.

Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).

January 10, 2020 · DrugView details →

Class IITerminated

ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

PD-Rx Pharmaceuticals, Inc.

CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

January 10, 2020 · DrugView details →

Class IITerminated

Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.

AVKARE Inc.

Failed Impurities/Degradation Specifications: High out of specification results for related compounds.

January 7, 2020 · DrugView details →

Class IIITerminated

Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.

Sigan Industries Inc.

Microbial contamination of non-sterile product.

January 7, 2020 · DrugView details →

Class IITerminated

Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.

Mylan Pharmaceuticals Inc.

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

January 7, 2020 · DrugView details →

Class IITerminated

Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.

Appco Pharma LLC

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

January 7, 2020 · DrugView details →

Class IITerminated

Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.

Mylan Pharmaceuticals Inc.

CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

January 7, 2020 · DrugView details →

Class IITerminated

Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)

Preferred Pharmaceuticals, Inc

CGMP Deviations: Presence of NDMA impurity detected in product.

January 7, 2020 · DrugView details →

Class IITerminated

Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)

Preferred Pharmaceuticals, Inc

CGMP Deviations: Presence of NDMA impurity detected in product.

January 7, 2020 · DrugView details →

← PreviousPage 313 of 889Next →