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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 17,221–17,240 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Lloyd Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

by Lloyd Inc. of Iowa

Reason
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Recall initiated
April 1, 2013
Reported by FDA
May 29, 2013
Distribution
The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Levothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1322-01

by Lloyd Inc. of Iowa

Reason
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Recall initiated
April 1, 2013
Reported by FDA
May 29, 2013
Distribution
The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Lloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

by Lloyd Inc. of Iowa

Reason
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Recall initiated
April 1, 2013
Reported by FDA
May 29, 2013
Distribution
The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Levothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1321-01

by Lloyd Inc. of Iowa

Reason
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Recall initiated
April 1, 2013
Reported by FDA
May 29, 2013
Distribution
The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC 60793-860-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

by King Legacy, a wholly owned subsidiary of Pfizer

Reason
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recall initiated
April 30, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC 60793-859-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

by King Legacy, a wholly owned subsidiary of Pfizer

Reason
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recall initiated
April 30, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

by King Legacy, a wholly owned subsidiary of Pfizer

Reason
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recall initiated
April 30, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

by King Legacy, a wholly owned subsidiary of Pfizer

Reason
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recall initiated
April 30, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC 60793-856-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

by King Legacy, a wholly owned subsidiary of Pfizer

Reason
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recall initiated
April 30, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC 60793-855-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

by King Legacy, a wholly owned subsidiary of Pfizer

Reason
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recall initiated
April 30, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

by King Legacy, a wholly owned subsidiary of Pfizer

Reason
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recall initiated
April 30, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

by King Legacy, a wholly owned subsidiary of Pfizer

Reason
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recall initiated
April 30, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

by King Legacy, a wholly owned subsidiary of Pfizer

Reason
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recall initiated
April 30, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

by King Legacy, a wholly owned subsidiary of Pfizer

Reason
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recall initiated
April 30, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 60793-850-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

by King Legacy, a wholly owned subsidiary of Pfizer

Reason
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recall initiated
April 30, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85

by Novartis Consumer Health

Reason
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Recall initiated
April 19, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.

by Aaron Industries Inc

Reason
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Recall initiated
April 4, 2013
Reported by FDA
May 29, 2013
Distribution
Nationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.

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Drug Recall Terminated Historical recordClass III

BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01

by Hi-Tech Pharmacal Co., Inc.

Reason
Subpotent; Cetylpyridinum Chloride
Recall initiated
April 8, 2013
Reported by FDA
May 22, 2013
Distribution
Puerto Rico

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Drug Recall Terminated Historical recordClass II

Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244

by NuVision Pharmacy, Inc.

Reason
Lack of Assurance of Sterility; reports of adverse events after injection
Recall initiated
March 28, 2013
Reported by FDA
May 22, 2013
Distribution
FL, MO, UT, and WA.

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Drug Recall Terminated Historical recordClass II

Zinc Sulfate Injection, all strengths and all presentations including a) Zinc Sulfate 10 mg/mL 30 mL and b) Zinc Sulfate 1 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

by FVS Holdings, Inc. dba. Green Valley Drugs

Reason
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Recall initiated
April 10, 2013
Reported by FDA
May 22, 2013
Distribution
Nationwide

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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.