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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

All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: October 6, 2012
Reported by FDA: November 21, 2012
Distribution: Nationwide Japan

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Drug Recall Terminated Historical recordClass III

Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30

by Stat Rx USA

Reason: Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Recall initiated: August 23, 2012
Reported by FDA: November 21, 2012
Distribution: GA and TN.

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Drug Recall Terminated Historical recordClass III

Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,

by Stat Rx USA

Reason: Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Recall initiated: June 18, 2012
Reported by FDA: November 21, 2012
Distribution: FL, PA, and VA.

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Drug Recall Terminated Historical recordClass III

AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2.

by Valeant Pharmaceuticals

Reason: Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Recall initiated: October 15, 2012
Reported by FDA: November 14, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9.

by Valeant Pharmaceuticals

Reason: Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Recall initiated: October 15, 2012
Reported by FDA: November 14, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6.

by Valeant Pharmaceuticals

Reason: Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Recall initiated: October 15, 2012
Reported by FDA: November 14, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.

by Valeant Pharmaceuticals

Reason: Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
Recall initiated: October 15, 2012
Reported by FDA: November 14, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7.

by Valeant Pharmaceuticals

Reason: Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Recall initiated: October 15, 2012
Reported by FDA: November 14, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.

by Valeant Pharmaceuticals

Reason: Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Recall initiated: October 15, 2012
Reported by FDA: November 14, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12900 3.

by Valeant Pharmaceuticals

Reason: Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Recall initiated: October 15, 2012
Reported by FDA: November 14, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6.

by Valeant Pharmaceuticals

Reason: Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
Recall initiated: October 15, 2012
Reported by FDA: November 14, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India

by Aurobindo Pharma LTD

Reason: Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
Recall initiated: March 9, 2012
Reported by FDA: November 14, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass I

Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.

by Merit Medical Systems, Inc

Reason: Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Recall initiated: February 24, 2006
Reported by FDA: November 14, 2012
Distribution: Connecticut, Maryland, Ohio, and South Carolina.

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Drug Recall Terminated Historical recordClass I

Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066

by Coral Rock Man, Inc.

Reason: Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Recall initiated: July 16, 2012
Reported by FDA: November 7, 2012
Distribution: Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.

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Drug Recall Terminated Historical recordClass I

X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, FL, Also, labeled as X-Rock 3 Day Pill For Erectile Refunction, Distributed by www. CoralXRock.Com, Florida Keys, Florida

by Coral Rock Man, Inc.

Reason: Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Recall initiated: July 16, 2012
Reported by FDA: November 7, 2012
Distribution: Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.

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Drug Recall Terminated Historical recordClass I

X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792.

by XRock Industries, LLC

Reason: Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
Recall initiated: April 21, 2012
Reported by FDA: November 7, 2012
Distribution: Products were distributed nationwide and internationally to Australia, Bahamas, Bermuda, Canada, Croatia, Curacao, New Zealand, Trinidad and Tobago, U.S. Virgin Islands, Jamaica, and United Kingdom.

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Drug Recall Terminated Historical recordClass II

Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)

by Ben Venue Laboratories Inc

Reason: Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Recall initiated: July 5, 2012
Reported by FDA: November 7, 2012
Distribution: Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403

by DermaCare, Inc.

Reason: Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
Recall initiated: September 17, 2012
Reported by FDA: November 7, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403

by DermaCare, Inc.

Reason: Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
Recall initiated: September 17, 2012
Reported by FDA: November 7, 2012
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet StreetRx Only* Carole Park QLD 4300, Australia* Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.SA ***

by Mylan Pharmaceuticals Inc.

Reason: Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
Recall initiated: August 7, 2012
Reported by FDA: October 31, 2012
Distribution: Nationwide.

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Data last updated: October 4, 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.