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Hikma Injectables USA Inc

Hikma Injectables USA Inc Recalls

All product recalls associated with Hikma Injectables USA Inc.

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Recall Summary

Total Recalls

1000

Past Year

742

Class I (Serious)

175

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 761–780 of 11123 recalls

Ketamine Injection 50mg (Hikma) – tamper seal issue (2024)

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Class IIModerate

FDADec 19, 2024Nationwide• Hikma Injectables USA Inc

Phenylephrine Injection (Hikma) – tamper seal issue (2024)

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Class IIModerate

FDADec 19, 2024Nationwide• Hikma Injectables USA Inc

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

1...37 383940 41...557

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Moderate

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Pediatric Uretero-Renoscope (Karl Storz) – Reprocessing Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

White Maeng Da Kratom (CorePack) - Salmonella Contamination (2024)

Possible Salmonella contamination of affected product.

FDADec 12, 2024Nationwide• COREPACK MANUFACTURING INC

Acetaminophen Tablets (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Acetaminophen Extra Strength 500mg 1000ct (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Diphenhydramine HCl 50mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Diphenhydramine HCl 25mg 100ct (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Diphenhydramine HCl 25mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Acetaminophen Regular Strength (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Acetaminophen Extra Strength 500mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Chlorpromazine Tablets 25mg (Glenmark) – Impurity Limit Exceeded (2024)

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Class IIModerate

FDADec 11, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Chlorpromazine Tablets 10mg (Glenmark) – Impurity Limit Exceeded (2024)

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Class IIModerate

FDADec 11, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Kenworth T440 (Kenworth) – Electrical System Software Problem (2024)

PACCAR Incorporated (PACCAR) is recalling certain 2021-2025 Peterbilt and Kenworth vehicles, equipped with Bendix EC80 Advanced Electronic Control Units (ECU). Please see the recall report for a complete list of models. Electrical noise and low signal to the power line carrier may cause the ECU to incorrectly process commands or stop functioning.

NHTSADec 9, 2024Nationwide• KENWORTH

Viking Travel Trailer (Viking) – Trailer LPG System Problem (2024)

Forest River, Inc (Forest River) is recalling certain 2024-2025 Clipper and Viking travel trailers. Please see the recall report for a complete list of models. The bottle bracket welds may break and cause the propane tank to detach from the vehicle.

NHTSADec 6, 2024Nationwide• VIKING TRAVEL TRAILERS

Duloxetine Capsules 30mg (Breckenridge) – CGMP Impurity Limit (2024)

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

Class IIModerate

FDADec 6, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules 60mg (Breckenridge) – CGMP Impurity Limit (2024)

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

Class IIModerate

FDADec 6, 2024Nationwide• Breckenridge Pharmaceutical, Inc

LINK MP Reconstruction System (Waldemar Link) – Incorrect Label Size (2024)

Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

FDADec 5, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany