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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 9,781–9,800 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Recall initiated
March 9, 2018
Reported by FDA
March 28, 2018
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01

by Pine Pharmaceuticals, LLC

Reason
Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Recall initiated
March 5, 2018
Reported by FDA
March 28, 2018
Distribution
NY only

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Drug Recall Terminated Historical recordClass II

DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.

by Fresenius Medical Care Renal Therapies Group, LLC

Reason
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Recall initiated
December 20, 2017
Reported by FDA
March 28, 2018
Distribution
Product was distributed throughout the United States to patients and clinics.

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Drug Recall Terminated Historical recordClass II

Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India NDC # 31722-705-30

by Hetero Labs Limited Unit V

Reason
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Recall initiated
February 13, 2018
Reported by FDA
March 21, 2018
Distribution
NJ and then distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60

by Hetero Labs Limited Unit V

Reason
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Recall initiated
February 13, 2018
Reported by FDA
March 21, 2018
Distribution
NJ and then distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038

by Novel Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
March 5, 2018
Reported by FDA
March 21, 2018
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Recall initiated
March 8, 2018
Reported by FDA
March 21, 2018
Distribution
Product was distributed Nationwide in the USA.

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Drug Recall Terminated Historical recordClass I

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01

by Pfizer Inc.

Reason
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Recall initiated
February 7, 2018
Reported by FDA
March 21, 2018
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01

by Pfizer Inc.

Reason
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Recall initiated
February 7, 2018
Reported by FDA
March 21, 2018
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients

by American Pharmaceutical Ingredients LLC

Reason
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Recall initiated
March 7, 2018
Reported by FDA
March 21, 2018
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3

by American Pharmaceutical Ingredients LLC

Reason
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Recall initiated
March 7, 2018
Reported by FDA
March 21, 2018
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass III

Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4.

by Alva-Amco Pharmacal Companies., Inc.

Reason
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Recall initiated
March 9, 2018
Reported by FDA
March 21, 2018
Distribution
Nationwide in the USA; Italy; Sweden; Germany; New Zealand; Netherlands; Australia; Moldova; United Kingdom; Mexico; Brazil; Chile; Greece; Spain; Norway; Belgium; Bulgaria

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Drug Recall Terminated Historical recordClass II

methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.

by Sagent Pharmaceuticals Inc

Reason
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Recall initiated
March 5, 2018
Reported by FDA
March 21, 2018
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.

by Sagent Pharmaceuticals Inc

Reason
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Recall initiated
March 5, 2018
Reported by FDA
March 21, 2018
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.

by Sagent Pharmaceuticals Inc

Reason
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Recall initiated
March 5, 2018
Reported by FDA
March 21, 2018
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10

by Mckesson Packaging Services

Reason
Failed Stability Specifications
Recall initiated
February 26, 2018
Reported by FDA
March 14, 2018
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028

by SCA Pharmaceuticals, LLC.

Reason
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
Recall initiated
February 22, 2018
Reported by FDA
March 14, 2018
Distribution
GA, NE & PA

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Drug Recall Terminated Historical recordClass I

Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015

by Bella All Natural

Reason
Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Recall initiated
February 14, 2018
Reported by FDA
March 14, 2018
Distribution
Product was distributed in California to online customers and retail stores.

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Drug Recall Terminated Historical recordClass II

Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.

by Bayer HealthCare Pharmaceuticals, Inc.

Reason
Labeling: Label mix-up
Recall initiated
February 23, 2018
Reported by FDA
March 14, 2018
Distribution
Arkansas only

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Drug Recall Terminated Historical recordClass III

Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by: Patheon Pharmaceuticals, Inc. Cincinnati OH 45237 Product of Switzerland NDC 0310-0657-58

by AstraZeneca Pharmaceuticals LP

Reason
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Recall initiated
February 23, 2018
Reported by FDA
March 14, 2018
Distribution
Nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.