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The Recall Registry is not a government service and does not issue recalls. We gather published recall notices from the U.S. Consumer Product Safety Commission, the U.S. Food and Drug Administration and the National Highway Traffic Safety Administration, and rewrite them in plain language. Always confirm the details with the issuing agency using the link on each recall page.

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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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1,991 recalls · newest first

Food & drug recall · FDAMarch 7, 2025Serious

Direct Rx — Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge

Prescription medicine · Direct Rx · 875 bottles affected

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Food & drug recall · FDAMarch 7, 2025Serious

Slate Run Pharmaceuticals — Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04

Prescription medicine · Slate Run Pharmaceuticals · 56,790 bottles affected

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Food & drug recall · FDAMarch 7, 2025Serious

Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 510

Prescription medicine · Mylan Institutional, Inc. · 1,068 cartons affected

Super-Potent Drug: Out of specification potency results were obtained.

Food & drug recall · FDAMarch 7, 2025Serious

Exela Pharma Sciences LLC — 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only

Prescription medicine · Exela Pharma Sciences LLC · 103,950 vials affected

Lack of Assurance of Sterility

Food & drug recall · FDAMarch 7, 2025Serious

ASEGUA THERAPEUTICS LLC — Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only

Prescription medicine · ASEGUA THERAPEUTICS LLC · 18,541 cartons. affected

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

Food & drug recall · FDAMarch 7, 2025Serious

Direct Rx — Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30

Prescription medicine · Direct Rx · 16 bottles affected

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Food & drug recall · FDAMarch 7, 2025Serious

Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 5107

Prescription medicine · Mylan Institutional, Inc. · 347 Cartons affected

Super-Potent Drug: Out of specification potency results were obtained.

Food & drug recall · FDAMarch 7, 2025Serious

Slate Run Pharmaceuticals — Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04

Prescription medicine · Slate Run Pharmaceuticals · 2,444 bottles affected

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Food & drug recall · FDAMarch 7, 2025Serious

Consumer Product Partners, LLC — [CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist. by: Amazon.com Services, LLC, Seattle

Prescription medicine · Consumer Product Partners, LLC · 25,932 bottles affected

Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol

Food & drug recall · FDAMarch 6, 2025Serious

QuVa Pharma, Inc. — fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Offi

Prescription medicine · QuVa Pharma, Inc. · 2,310 cassettes affected

Lack of Assurance of Sterility

Food & drug recall · FDAMarch 6, 2025Serious

QuVa Pharma, Inc. — fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Us

Prescription medicine · QuVa Pharma, Inc. · 1,765 cassettes affected

Lack of Assurance of Sterility

Food & drug recall · FDAMarch 6, 2025Serious

QuVa Pharma, Inc. — fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Us

Prescription medicine · QuVa Pharma, Inc. · N/A affected

Lack of Assurance of Sterility

Food & drug recall · FDAMarch 5, 2025Serious

Strides Pharma, Inc. — Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only

Prescription medicine · Strides Pharma, Inc. · 195,952 Cartons; 30 sachets/Carton. affected

Presence of foreign substance: Presence of Benzene.

Food & drug recall · FDAMarch 5, 2025Serious

Strides Pharma, Inc. — Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only

Prescription medicine · Strides Pharma, Inc. · 244,412 Cartons; 30 sachets /Carton affected

Presence of foreign substance: Presence of Benzene.

Food & drug recall · FDAMarch 5, 2025Serious

Rising Pharma Holding, Inc. — Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only

Prescription medicine · Rising Pharma Holding, Inc. · 1223 bottles affected

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Food & drug recall · FDAMarch 5, 2025Serious

Golden State Medical Supply Inc. — PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30

Prescription medicine · Golden State Medical Supply Inc. · 2,601 30-count bottles affected

Failed Dissolution Specifications

Food & drug recall · FDAMarch 5, 2025Serious

L'Oreal USA — La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz. (100 mL) Tube, Clarifying Solution 3.4 fl. oz. (100 mL) Tube, Dual Action Acne Treatmen

Prescription medicine · L'Oreal USA · 14,460 bottles affected

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an…

Food & drug recall · FDAMarch 5, 2025Serious

L'Oreal USA — La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-P

Prescription medicine · L'Oreal USA · 2,226,801 bottles affected

Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.

Food & drug recall · FDAMarch 5, 2025Serious

L'Oreal USA — La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube pe

Prescription medicine · L'Oreal USA

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an…

Food & drug recall · FDAMarch 4, 2025Labelling issue

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianap

Prescription medicine · The Harvard Drug Group LLC dba Major… · 224 cartons affected

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

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