PlainRecalls

2018 Recalls

6,355 recalls · Page 54 of 128

2018 Recall Year Insight

Federal agencies issued 6,355 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.57% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 17.4 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 128 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2018.

On this page of 50 records, severity classification shows 5 critical, 37 moderate, and 8 lower-severity recalls. The page references 24 distinct recalling firms operating in 7 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Drug (26), FDA Food (13), FDA Devices (11), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ — an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2018 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number — always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Food Low Aug 1, 2018

Sisel, SiselRipt, postWORKOUT, Dietary supplement, net wt 5g (0.17 oz), Internal Company Number F137315-10-01

Sisel International Llc

FDA Food Moderate Aug 1, 2018

Superfood Salad Kit - 6.8 lbs. - sold to Kroger owned stores and prepared and purchased at deli department at retail stores. Size purchased is depen…

Papa John's Salads & Produce, Inc.

FDA Food Moderate Aug 1, 2018

Kowalski's Markets kalbi rub. Net Wt 5.5 oz. (155.9 g), UPC 79147-00243. Distributed by: Kowalski's Markets, Woodbury, MN 55125

J and J Bunting, Inc

FDA Food Critical Aug 1, 2018

Europe's Best Field Berry Mix 12/600g (Strawberries, Blueberries, Blackberries)

Holley Cold Storage Fruit & Produce Co., Inc.

FDA Food Moderate Aug 1, 2018

Soy Honey Cluster 30 lb. case, plastic bag in cardboard box Product code 30666529.137

Kerry Inc

FDA Food Critical Aug 1, 2018

3+2 Soda Crackers (CREAM FLAVOUR)(S) packaged in a 4.4 oz, yellow package, UPC: 6 919892 633101

May Flower International Inc.

FDA Food Low Aug 1, 2018

Amino Life brand Product - BCAA 2:1:1 Instant Sunflower 25 Kgs Fiber carton double layer polyethylene bag as liner

Prinova US LLC

FDA Food Critical Aug 1, 2018

Europe's Best Bananas & Berries 12/600g (Bananas, Strawberries, Blueberries)

Holley Cold Storage Fruit & Produce Co., Inc.

FDA Food Critical Aug 1, 2018

Europe's Best 4-Field Berry Mix 12/600g and 6/2kg (Blackberries, Strawberries, Blueberries, Raspberries)

Holley Cold Storage Fruit & Produce Co., Inc.

FDA Food Critical Aug 1, 2018

Canoodles (ACN) coarse ground cold smoked dehydrated shelf stable sockeye salmon pieces

Tilgner's Alaskan Salmon

FDA Food Low Aug 1, 2018

Amino Life brand Product - L-Leucine Instant Sunflower 25 Kgs Fiber carton double layer polyethylene bag as liner

Prinova US LLC

FDA Food Moderate Aug 1, 2018

AMPI Whey Powder, Sweet Type, Formula 521, Extra Grade, spray process pasteurized, packaged in 50 lbs net (22.68 kg net) and 25 kg net (55.12 lbs net…

AMPI

FDA Food Moderate Aug 1, 2018

HEB Creamy Creations Orange and Lime Sherbet Cup 3 oz packaged in a 12 count plastic bag - (6-3oz. Orange Flavored Sherbet cups and 6-3oz. Lime Flavo…

H-E-B GROCERY COMPANY LP DBA HEB

FDA Drug Low Aug 1, 2018

Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area,…

MAJOR PHARMACEUTICALS

FDA Drug Moderate Aug 1, 2018

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmace…

Prinston Pharmaceutical Inc

FDA Drug Moderate Aug 1, 2018

Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.

MAJOR PHARMACEUTICALS

FDA Drug Moderate Aug 1, 2018

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (M…

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 1, 2018

Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pha…

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 1, 2018

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Mal…

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 1, 2018

Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Phar…

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 1, 2018

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Lt…

Teva Pharmaceuticals USA

FDA Drug Low Aug 1, 2018

Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-30

Aidarex Pharmaceuticals LLC

FDA Drug Moderate Aug 1, 2018

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmac…

Prinston Pharmaceutical Inc

FDA Drug Moderate Aug 1, 2018

Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma…

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 1, 2018

Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Phar…

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 1, 2018

Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linha…

Prinston Pharmaceutical Inc

FDA Drug Moderate Aug 1, 2018

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (…

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 1, 2018

Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linha…

Prinston Pharmaceutical Inc

FDA Drug Low Aug 1, 2018

Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90

Aidarex Pharmaceuticals LLC

FDA Drug Moderate Aug 1, 2018

Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Lin…

Prinston Pharmaceutical Inc

FDA Drug Moderate Aug 1, 2018

Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Lin…

Prinston Pharmaceutical Inc

FDA Drug Low Aug 1, 2018

Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Are…

MAJOR PHARMACEUTICALS

FDA Drug Moderate Aug 1, 2018

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharma…

Prinston Pharmaceutical Inc

FDA Drug Moderate Aug 1, 2018

Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manu…

Sun Pharmaceutical Industries, Inc.

FDA Drug Moderate Aug 1, 2018

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharm…

Prinston Pharmaceutical Inc

FDA Drug Moderate Aug 1, 2018

Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Ma…

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 1, 2018

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharma…

Prinston Pharmaceutical Inc

FDA Drug Low Aug 1, 2018

Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90

Aidarex Pharmaceuticals LLC

FDA Drug Moderate Aug 1, 2018

Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.

MAJOR PHARMACEUTICALS

FDA Devices Moderate Aug 1, 2018

ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorat…

Implant Direct Sybron Manufacturing, LLC

FDA Devices Moderate Aug 1, 2018

PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)

Ethicon, Inc.

FDA Devices Moderate Aug 1, 2018

Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and u…

Nobel Biocare Usa Llc

FDA Devices Moderate Aug 1, 2018

PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)

Ethicon, Inc.

FDA Devices Moderate Aug 1, 2018

Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for moni…

Bard Medical Division

FDA Devices Moderate Aug 1, 2018

CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM…

Abbott Laboratories, Inc.

FDA Devices Moderate Aug 1, 2018

ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Aug 1, 2018

2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm …

IMPLANTCAST GMBH

FDA Devices Moderate Aug 1, 2018

Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R

Olympus Corporation of the Americas

FDA Devices Moderate Aug 1, 2018

Uretero-reno fiberscope URF-P6RP6

Olympus Corporation of the Americas

FDA Devices Moderate Aug 1, 2018

GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.

Life Technologies, Corp.

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2018 with 2017 →

Data Sources

  • Source: FDA openFDA Enforcement API — calendar-year recall filings for food, drugs, and devices
  • Source: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2018