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Hikma Pharmaceuticals USA Inc.

Hikma Pharmaceuticals USA Inc. Recalls

All product recalls associated with Hikma Pharmaceuticals USA Inc..

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Recall Summary

Total Recalls

1000

Past Year

726

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 3381–3400 of 11124 recalls

Sodium Chloride Injection (Hikma) – pH Specification (2020)

Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.

Class IIModerate

FDANov 3, 2020Nationwide• Hikma Pharmaceuticals USA Inc.

Bulldog Endoscope Valves (GA Health) – Valve Malfunction (2020)

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

Moderate

FDANov 3, 2020Nationwide• GA HEALTH COMPANY LIMITED Unit 18, 21/F Metropole Square; 2 On Yiu Street ,Shatin, N.T Shatin N.T. Hong Kong SAR

Keystone Cougar (Keystone) – Solar Inverter Failure (2020)

Keystone RV Company (Keystone) is recalling certain 2020-2021 Cougar trailers equipped with the Off the Grid (OTG) Solar package. The inverter may have been incorrectly wired, causing power to energize the shore power connection, when in use.

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Moderate

NHTSAOct 30, 2020Nationwide• KEYSTONE

Mesalamine Tablets (AVKARE) – Dissolution Failure (2020)

Failed Dissolution Specifications

Class IIModerate

FDAOct 30, 2020Nationwide• AVKARE Inc.

Oven Liners (Gorilla Commerce) – Carbon Monoxide (2020)

Laceration Risk

This recall involves Gorilla Commerce heavy duty oven liners. The black fiberglass liners were sold in a set of three. Extra Thick and Gorilla Grip with a gorilla logo is printed on the packaging.

Very High

CPSCOct 29, 2020Nationwide• Keli New Materials Co. Ltd, of Zhejiang, China

Ron Jon Sippy Cup – Lead Content Violation (2020)

This recall involves 13.5-ounce Ron Jon Surf Sippy Cups. The main body of the cup is either orange, blue, pink, or green. There is a rubber-like grip material around the cup. The rubber-like material has images of turtle, crab, fish, boat, and sea grass and the RON JON SURF SHOP design. The product has UPC number 1082-0405 printed on the bottom of the product.

Moderate

CPSCOct 28, 2020Nationwide• Yitak Industry Company Limited, of China

MANI Trocar Kit (Mani) – Luer Connector Failure (2020)

Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use

Moderate

FDAOct 27, 2020Nationwide• Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan

MANI Infusion Cannula (Mani) – Luer Connector Failure (2020)

Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use

Moderate

FDAOct 27, 2020Nationwide• Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan

Elderberries Whole Organic (Natural Grocers) – Salmonella Risk (2020)

Salmonella

Potential contamination with Salmonella.

Class IIModerate

FDAOct 27, 2020AZ, AR, CO +17 more• Vitamin Cottage Natural Foods Market, Inc DBA Natural Grocers

BD Ultra-Fine Pen Needles (Becton Dickinson) – Mislabeling (2020)

Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing.

Moderate

FDAOct 23, 2020Nationwide• Becton Dickinson & Company

Mako Integrated Cutting System (Mako) – Handpiece Characterization (2020)

Laceration Risk

Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.

Moderate

FDAOct 23, 2020Nationwide• Mako Surgical Corporation

Wintergreen Essential Oil (Rocky Mountain Oils) – Safety Concern (2020)

This recall involves Rocky Mountain Oils Wintergreen essential oil, and oil blends Pain Ease, Sports Pro, True Blue, and Relieve Me in 15 mL amber glass bottles with black caps. "Wintergreen," "Pain Ease," "Sports Pro," "True Blue," and "Relieve Me" along with the firm's logo and volume amount are displayed on the front. The UPC codes are displayed on the back of the bottle. The lot code is located on the bottom of the bottle. Product SKU UPC Lot Codes Wintergreen WINNEP-S15 053176176888 2129, 2596, 2893, 3298, 3558, 3670, 3822, 3990, 11115, 60517, 80217, 300116, 310916, 420316, 471115, 651216, 820616, 941116 Pain Ease PAINEA-B15 053176178387 2068, 2429, 2724, 3393, 3865, 40416, 50117, 140216, 170217, 201215, 201216, 220317, 220717, 220916, 391016, 630616 Sports Pro SPONEA-B15 053176178790 2016, 2571, 3700, 4129, 10716, 80117, 150216, 211215, 640916 True Blue TRUNEA-B15 053176178899 2051, 2588, 2750, 3701, 3949, 3950, 11016, 100117, 190716, 290716, 441215, 550116, 701116 Relieve Me RELNEA-B15 053176178547 2214, 2766, 3412, 3691, 4091, 30316, 110316, 250417, 351215, 380216, 401016, 641116, 801216, 960616, 991016

Low

CPSCOct 22, 2020Nationwide• Rocky Mountain Oils, of Orem, Utah

Fixed Core Wire Guide (Cook) – Manufacturing Damage (2020)

Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.

Moderate

FDAOct 22, 2020AZ, IN, IA +2 more• Cook Inc.

Volkswagen Jetta (Volkswagen) – Fuel Rail Bolt Risk (2020)

Fire/Burn Risk

Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2016-2018 Jetta vehicles. The fuel rail bolts may become loose over time, allowing fuel to leak.

High

NHTSAOct 21, 2020Nationwide• VOLKSWAGEN

Zyphr Cranial Perforator (Stryker) – Inner Bit Crack Risk (2020)

Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.

High

FDAOct 16, 2020Nationwide• Stryker Instruments Div. of Stryker Corporation

Cup Jelly Mini (Hadson Trading) – Choking Risk (2020)

Choking Hazard

Product is a choking hazard.

Class IHigh

FDAOct 14, 2020CO, CT, FL +18 more• Hadson (Toko) Trading Co., Inc.

Metformin HCL Extended-Release 750mg (RemedyRepack) – NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class IIModerate

FDAOct 11, 2020IN, PA• RemedyRepack Inc.

Herbes de Provence (Red Monkey Foods) – Salmonella Risk (2020)

Salmonella

An ingredient (parsley) which was repacked into consumer packages and used to manufacture other herb blends tested positive for Salmonella and was recalled by the supplier.

Class IHigh

FDAOct 9, 2020Nationwide• Red Monkey Foods Inc

Dried Parsley (Red Monkey Foods) – Salmonella Risk (2020)

Salmonella

An ingredient (parsley) which was repacked into consumer packages and used to manufacture other herb blends tested positive for Salmonella and was recalled by the supplier.

Class IHigh

FDAOct 9, 2020Nationwide• Red Monkey Foods Inc

RayStation Software (RaySearch) – Import Mapping Issue (2020)

If a region of interest (ROI) or point of interest (POI) that is referenced from an imported plan is missing in the imported RT Structure Set, the reference may become linked to the wrong ROI or POI.

High

FDAOct 8, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden