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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 17,441–17,460 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01.

by Zydus Pharmaceuticals USA Inc

Reason
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Recall initiated
March 5, 2013
Reported by FDA
April 3, 2013
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK --- NDC 54868-4507-00

by Physicians Total Care, Inc.

Reason
Subpotent; 15 month stability (by mfr)
Recall initiated
November 15, 2012
Reported by FDA
March 27, 2013
Distribution
OH, GA

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Drug Recall Terminated Historical recordClass III

4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

by Novartis Consumer Health

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Recall initiated
March 7, 2013
Reported by FDA
March 27, 2013
Distribution
Nationwide and Panama

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Drug Recall Terminated Historical recordClass III

4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

by Novartis Consumer Health

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Recall initiated
March 7, 2013
Reported by FDA
March 27, 2013
Distribution
Nationwide and Panama

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Drug Recall Terminated Historical recordClass III

4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

by Novartis Consumer Health

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Recall initiated
March 7, 2013
Reported by FDA
March 27, 2013
Distribution
Nationwide and Panama

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Drug Recall Terminated Historical recordClass III

Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

by Novartis Consumer Health

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Recall initiated
March 7, 2013
Reported by FDA
March 27, 2013
Distribution
Nationwide and Panama

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Drug Recall Terminated Historical recordClass III

Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054.

by Novartis Consumer Health

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Recall initiated
March 7, 2013
Reported by FDA
March 27, 2013
Distribution
Nationwide and Panama

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Drug Recall Terminated Historical recordClass II

METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)

by Hospira Inc.

Reason
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
Recall initiated
February 15, 2013
Reported by FDA
March 27, 2013
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28

by Watson Laboratories Inc

Reason
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Recall initiated
February 13, 2013
Reported by FDA
March 27, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01

by Watson Laboratories Inc

Reason
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Recall initiated
February 8, 2013
Reported by FDA
March 27, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 9591-5239-01

by Watson Laboratories Inc

Reason
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Recall initiated
February 8, 2013
Reported by FDA
March 27, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.

by West-Ward Pharmaceutical Corp.

Reason
Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
Recall initiated
November 30, 2012
Reported by FDA
March 27, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10

by Fresenius Kabi USA LLC (FK USA)

Reason
Labeling: Missing label
Recall initiated
February 1, 2013
Reported by FDA
March 20, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04

by AstraZeneca LP

Reason
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Recall initiated
January 11, 2013
Reported by FDA
March 20, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04

by AstraZeneca LP

Reason
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Recall initiated
January 11, 2013
Reported by FDA
March 20, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic, Sold under the following brands: a) Good Neighbor Pharmacy, NDC 24385-593-46; b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value; e) CVS Pharmacy; f) Rite Aid Pharmacy; g) Top Care; h) HEB; and i) Humco.

by Humco Holding Group, Inc

Reason
Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.
Recall initiated
January 17, 2013
Reported by FDA
March 20, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090

by A B Nutrition, Inc.

Reason
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Recall initiated
May 27, 2011
Reported by FDA
March 20, 2013
Distribution
In retail store located in TX and internet sales nationwide.

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Drug Recall Terminated Historical recordClass II

PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090

by A B Nutrition, Inc.

Reason
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Recall initiated
May 27, 2011
Reported by FDA
March 20, 2013
Distribution
In retail store located in TX and internet sales nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090

by A B Nutrition, Inc.

Reason
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Recall initiated
May 27, 2011
Reported by FDA
March 20, 2013
Distribution
In retail store located in TX and internet sales nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India - 382 210; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.

by Teva Pharmaceuticals USA, Inc.

Reason
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Recall initiated
January 23, 2013
Reported by FDA
March 20, 2013
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.