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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

Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

by West-Ward Pharmaceutical Corp.

Reason: Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
Recall initiated: November 30, 2012
Reported by FDA: January 30, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724.

by West-Ward Pharmaceutical Corp.

Reason: Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
Recall initiated: December 7, 2012
Reported by FDA: January 30, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.

by West-Ward Pharmaceutical Corp.

Reason: Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
Recall initiated: December 7, 2012
Reported by FDA: January 30, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031

by James G. Cole, Inc.

Reason: Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
Recall initiated: August 28, 2012
Reported by FDA: January 23, 2013
Distribution: Product was distributed nationwide and Canada

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Drug Recall Terminated Historical recordClass III

CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88

by Teva Pharmaceuticals USA, Inc.

Reason: Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Recall initiated: April 24, 2012
Reported by FDA: January 23, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.

by Upsher Smith Laboratories, Inc.

Reason: Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Recall initiated: December 10, 2012
Reported by FDA: January 23, 2013
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.

by Boehringer Ingelheim Roxane Inc

Reason: Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Recall initiated: December 12, 2012
Reported by FDA: January 23, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040.

by L. Perrigo Co.

Reason: Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. This is a sub-recall due to tablets contaminated with trace amounts of food-grade lubricant, as well as stainless steel inclusions
Recall initiated: December 17, 2012
Reported by FDA: January 23, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: September 26, 2012
Reported by FDA: January 9, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: September 26, 2012
Reported by FDA: January 9, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: September 26, 2012
Reported by FDA: January 9, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: September 26, 2012
Reported by FDA: January 9, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: September 26, 2012
Reported by FDA: January 9, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: September 26, 2012
Reported by FDA: January 9, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: September 26, 2012
Reported by FDA: January 9, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: September 26, 2012
Reported by FDA: January 9, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: September 26, 2012
Reported by FDA: January 9, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: September 26, 2012
Reported by FDA: January 9, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: September 26, 2012
Reported by FDA: January 9, 2013
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA

by New England Compounding Center

Reason: Lack of Assurance of Sterility
Recall initiated: September 26, 2012
Reported by FDA: January 9, 2013
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.