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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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Prescription medicine1,991 Over-the-counter & supplements377 Mobility & home health182

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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 · FDAOctober 31, 2025Serious

Blossom Pharmaceuticals — Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g)

Prescription medicine · Blossom Pharmaceuticals · 12150 bottles affected

cGMP deviations

Food & drug recall · FDAOctober 31, 2025Serious

Cipla Limited — Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708

Prescription medicine · Cipla Limited · 4,438 10x1mL cartons affected

Failed Stability Specifications: Observed OOS results: eg results for colour index

Food & drug recall · FDAOctober 31, 2025Serious

Novocol Pharmaceutical of Canada, Inc. — Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distribut

Prescription medicine · Novocol Pharmaceutical of Canada, Inc.

Defective container: cracked/broken cartridges

Food & drug recall · FDAOctober 29, 2025Highest risk

Otsuka ICU Medical LLC — POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14

Prescription medicine · Otsuka ICU Medical LLC · 21,696 50mL flexible containers affected

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj.

Food & drug recall · FDAOctober 29, 2025Highest risk

Otsuka ICU Medical LLC — POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26

Prescription medicine · Otsuka ICU Medical LLC

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj.

Food & drug recall · FDAOctober 28, 2025Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · N/A affected

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…

Food & drug recall · FDAOctober 28, 2025Serious

Agebox — Agebox iKids-Growth (Night Formula), 60-count bottles

Prescription medicine · Agebox · N/A affected

Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

Food & drug recall · FDAOctober 28, 2025Serious

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

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · N/A affected

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…

Food & drug recall · FDAOctober 28, 2025Serious

Agebox — Agebox iKids-Growth (Day Formula) capsules, 60-count bottles

Prescription medicine · Agebox · 665 bottles affected

Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

Food & drug recall · FDAOctober 28, 2025Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · N/A affected

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…

Food & drug recall · FDAOctober 28, 2025Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · N/A affected

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…

Food & drug recall · FDAOctober 28, 2025Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · N/A affected

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…

Food & drug recall · FDAOctober 28, 2025Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · N/A affected

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…

Food & drug recall · FDAOctober 28, 2025Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · N/A affected

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…

Food & drug recall · FDAOctober 27, 2025Serious

Otsuka ICU Medical LLC — 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

Prescription medicine · Otsuka ICU Medical LLC · 509,360 100 mL bags affected

Lack of Assurance of Sterility: Potential for flexible container leaks.

Food & drug recall · FDAOctober 24, 2025Serious

Cipla USA, Inc. — Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only

Prescription medicine · Cipla USA, Inc. · N/A affected

Failed stability specifications: Out of specification for hardness test

Food & drug recall · FDAOctober 24, 2025Serious

Cipla USA, Inc. — Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only

Prescription medicine · Cipla USA, Inc. · 1180 boxes affected

Failed stability specifications: Out of specification for hardness test

Food & drug recall · FDAOctober 23, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 6838

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · 36,624 bottles affected

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate…

Food & drug recall · FDAOctober 22, 2025Serious

Zydus Pharmaceuticals (USA) Inc — clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · N/A affected

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…

Food & drug recall · FDAOctober 22, 2025Serious

Zydus Pharmaceuticals (USA) Inc — clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · N/A affected

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…

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