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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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Highest riskSeriousWorth checkingLabelling issueTap any recall for the hazard and what to do

1,991 recalls · newest first

Food & drug recall · FDAJune 27, 2025Serious

Lupin Pharmaceuticals Inc. — clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01

Prescription medicine · Lupin Pharmaceuticals Inc. · 2,724 bottles affected

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation…

Food & drug recall · FDAJune 27, 2025Highest risk

Sandoz Inc — Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only

Prescription medicine · Sandoz Inc · unknown affected

Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20…

Food & drug recall · FDAJune 27, 2025Highest risk

Sandoz Inc — Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only

Prescription medicine · Sandoz Inc · 208,300 vials affected

Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection,…

Food & drug recall · FDAJune 26, 2025Labelling issue

AvKARE — Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only

Prescription medicine · AvKARE · 8,573 bottles affected

Failed Impurity/Degradation Specifications

Food & drug recall · FDAJune 26, 2025Labelling issue

AvKARE — Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only

Prescription medicine · AvKARE · 1,560 bottles affected

Failed Impurity/Degradation Specifications

Food & drug recall · FDAJune 24, 2025Serious

Granules Pharmaceuticals Inc. — Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only

Prescription medicine · Granules Pharmaceuticals Inc. · 27,648 100-count Bottles; 5,376 500-count Bottles affected

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH)…

Food & drug recall · FDAJune 20, 2025Serious

ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only

Prescription medicine · ACCORD HEALTHCARE, INC. · 9,739 bottles affected

Subpotent Drug: Assay below the approved specification

Food & drug recall · FDAJune 20, 2025Serious

ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only

Prescription medicine · ACCORD HEALTHCARE, INC. · 4,896 bottles affected

Subpotent Drug: Assay below the approved specification

Food & drug recall · FDAJune 20, 2025Serious

ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only

Prescription medicine · ACCORD HEALTHCARE, INC. · 4,921 bottles affected

Subpotent Drug: Assay below the approved specification

Food & drug recall · FDAJune 20, 2025Serious

Lupin Pharmaceuticals Inc. — Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202

Prescription medicine · Lupin Pharmaceuticals Inc. · 58,968 bottles affected

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets…

Food & drug recall · FDAJune 20, 2025Serious

ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only

Prescription medicine · ACCORD HEALTHCARE, INC. · 2,344 bottles affected

Subpotent Drug: Assay below the approved specification

Food & drug recall · FDAJune 20, 2025Serious

ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only

Prescription medicine · ACCORD HEALTHCARE, INC. · 82,159 bottles affected

Subpotent Drug: Assay below the approved specification

Food & drug recall · FDAJune 20, 2025Serious

ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only

Prescription medicine · ACCORD HEALTHCARE, INC. · 2,352 bottles affected

Subpotent Drug: Assay below the approved specification

Food & drug recall · FDAJune 20, 2025Serious

ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only

Prescription medicine · ACCORD HEALTHCARE, INC. · 54,227 bottles affected

Subpotent Drug: Assay below the approved specification

Food & drug recall · FDAJune 19, 2025Serious

The Harvard Drug Group LLC — Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61

Prescription medicine · The Harvard Drug Group LLC · 23,232 cartons affected

Defective container; blister packaging inadequately sealed.

Food & drug recall · FDAJune 19, 2025Serious

The Harvard Drug Group LLC — Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA

Prescription medicine · The Harvard Drug Group LLC · 3,527 bags affected

Defective container; blister packaging inadequately sealed.

Food & drug recall · FDAJune 16, 2025Labelling issue

Qualgen, LLC — Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01

Prescription medicine · Qualgen, LLC · 2,832 amber vials affected

Labeling: Incorrect or Missing Lot and/or Exp.

Food & drug recall · FDAJune 16, 2025Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 5,448 bottles affected

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability…

Food & drug recall · FDAJune 16, 2025Serious

B BRAUN MEDICAL INC — 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.

Prescription medicine · B BRAUN MEDICAL INC · 187,656 containers affected

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

Food & drug recall · FDAJune 11, 2025Labelling issue

Macleods Pharmaceuticals Ltd — Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only

Prescription medicine · Macleods Pharmaceuticals Ltd · 9,888/ 30 count bottles affected

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

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