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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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Drug Recall Terminated Historical recordClass II

FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105

by Faria Limited LLC dba Sheffield Pharmaceuticals

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Recall initiated: November 22, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320

by Faria Limited LLC dba Sheffield Pharmaceuticals

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Recall initiated: November 22, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (single blister).

by Teva Pharmaceuticals USA

Reason: Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Recall initiated: December 18, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister).

by Teva Pharmaceuticals USA

Reason: Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Recall initiated: December 18, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

by PACK Pharmaceuticals, LLC

Reason: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Recall initiated: September 9, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

by PACK Pharmaceuticals, LLC

Reason: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Recall initiated: September 9, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

by PACK Pharmaceuticals, LLC

Reason: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Recall initiated: September 9, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

by PACK Pharmaceuticals, LLC

Reason: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Recall initiated: September 9, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

by PACK Pharmaceuticals, LLC

Reason: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Recall initiated: September 9, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.

by PACK Pharmaceuticals, LLC

Reason: Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Recall initiated: September 9, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.

by Health & Beyond

Reason: Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)
Recall initiated: May 15, 2013
Reported by FDA: February 12, 2014
Distribution: Product was distributed to consumers through firm's website in Florida, Hawaii, California, Illinois, New York, Washington, and Pennsylvania.

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Drug Recall Terminated Historical recordClass II

The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.

by Apothecure, Inc

Reason: Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Recall initiated: April 15, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05.

by Forest Pharmaceuticals Inc

Reason: Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Recall initiated: November 13, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Namenda XR (memantine HCl), titration pack (7 mg, 14 mg, 21 mg and 28 mg) extended release capsules, packaged in 28-capsule, 4 week, titration pack,Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3400-29.

by Forest Pharmaceuticals Inc

Reason: Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Recall initiated: November 13, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass III

Namenda XR (memantine HCl), 7 mg extended release capsules, 30-count bottle, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045, NDC 0456-3407-33

by Forest Pharmaceuticals Inc

Reason: Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Recall initiated: November 13, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH

by Central Shared Services dba Parallon

Reason: CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.
Recall initiated: August 23, 2013
Reported by FDA: February 12, 2014
Distribution: GA, KY, TN

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Drug Recall Terminated Historical recordClass II

Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56

by Teva Pharmaceuticals USA, Inc.

Reason: Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
Recall initiated: November 8, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)

by Actavis Inc

Reason: Failed Tablet/Capsule Specifications: Broken tablets
Recall initiated: March 22, 2013
Reported by FDA: February 12, 2014
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2

by Greenstone Llc

Reason: Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Recall initiated: November 4, 2013
Reported by FDA: February 12, 2014
Distribution: US Nationwide (including PR)

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Drug Recall Terminated Historical recordClass III

Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66

by Pfizer Inc.

Reason: Failed Dissolution Specification; 8 hr stability timepoint
Recall initiated: November 4, 2013
Reported by FDA: February 12, 2014
Distribution: US nationwide (including PR)

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Data last updated: October 1, 2026 ET

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.