Is Acetaminophen 500 mg Caplet, 250 count bags (NDC 61392-948-25) & 30 count boxes (NDC 61392-948-30), OTC, Pkg by Heartland Repack, Toledo, OH recalled?

Mispacked; correct labeled product may be mispacked Distribution: The recalled products were distributed to pharmacy/ customers in the following locations nationwide: TX, NV, MD, FL, NJ, OH, RI, WI, IL, GA, AR, CA, WA, MS, KY, AZ, LA, IN, PA, OR, TN, VA, WV, MO, ID, MA, NM, NY, MT, KS, NH, SC, VT, IA, NC, CO, ME, MN, NE, NV, SD, MI, AL, UT, and CT.

Medium RiskFDA Drug

Heartland Repack Services LLC: Mispacked; correct labeled product may be mispacked

Agency Publication Date: October 20, 2006

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 35963

Status: Resolved

Manufacturer: Heartland Repack Services LLC

Manufactured In: United States

Units Affected: 194 products (96/250 count bags & 1603/30 count boxes; 4/250 count bags & 340/60 count boxes; 2137/250 count bags & 4131/30 count boxes; 117/250 count bags, 1610/30 count boxes, 31/60 count boxes, & 25/90 count boxes; 107/250 count bags & 951/30 count boxes; 3659/30counts boxes, 86/60 count boxes, 20/90 count boxes; 219/250 count bags & 7511/30 count boxes; 49/250 count bags & 1575/30 count boxes; 273/250 count bags, 1270/30 count boxs & 1046/60 count boxes; 61/250 count bags, 3298/30 count boxes & 451/60 count boxes; 110/250 count bags, 1949/30 count boxes & 4/60 count boxes; 277/250 count bags, 9073/30 count boxes & 48/60 count boxes; 179/250 count bags, 5163/30 count boxes & 18/60 count boxes; 695/30 count boxes; 79/250 counts bags & 1565/30 count boxes; 518/250 count bags & 11,282/30 count boxes; 116/250 count bags & 2219/30 count boxes; 90/250 count bags & 610/30 count boxes; 314/250 count bags, 11,003/30 count boxes & 201/60 count boxes; 1321/30 count boxes; 143/250 count bags, 717/30 count boxes & 500/60 count boxes; 40/250 count bags & 1,127/30 count boxes; 69/250 count bags & 925/30 count boxes; 523/250 count bags & 10,558/30 count boxes; 1278/250 count bags & 29,642/30 count boxes; 27/250 count bags & 768/30 count boxes; 45/250 count bags & 1199/30 count boxes; 7/250 count bags & 304/30 count boxes; 167/250 count bags, 1600/30 count boxes, 103/60 count boxes & 8/90 count boxes; 54/250 count bags, 707/30 count boxes, 190/60 count boxes & 25/90 count boxes; 196/250 count bags & 3587/30 count boxes; 75/250 count bags & 1905/30 count boxes; 66/250 count bags & 2712/30 count boxes; 352/250 count bags & 6840/30 count boxes; 144/250 count bags & 3631/30 count boxes; 104/250 count bags & 2768/30 count boxes; 228/250 count bags & 2911/30 count boxes; 178/250 count bags & 2974/30 count boxes; 78/250 count bags & 2587/30 count boxes; 15,222/30 count boxes & 2945/60 count boxes; 719/250 count bags & 15,081/30 count boxes; 8661/30 count boxes & 2033/60 count boxes; 265/250 count bags, 1631/30 count boxes & 1070/60 count boxes; 59/250 count bags & 1916/30 count boxes; 238/250 count bags, 759/30 count boxes & 298/60 count boxes; 318/250 count bags, 1850/30 count boxes, 17/60 count boxes & 30/90 count boxes; 167/250 count bags & 2954/30 count boxes; 140/250 count bags & 2368/30 count boxes; 308/250 count bags, 263/30 count boxes, 1808/60 count boxes, & 803/90 count boxes; 33/250 count bags & 3493/30 count boxes; 18/250 count bags & 395/30 count boxes; 45/250 count bags & 720/30 count boxes; 81/250 count bags, 2773/30 count boxes & 615/60 count boxes; 4/250 count bags, 2845/30 count boxes, 564/60 count boxes & 199/90 count boxes; 335/250 count bags & 1860/30 count boxes; 153/250 count bags, 6355/30 count boxes, & 221/60 count boxes; 66/250 count bags & 1406/30 count boxes; 277/250 count bags & 1042/30 count boxes; 109/250 count bags, 2895/30 count boxes & 69/60 count boxes; 4/250 count bags & 268/30 count boxes; 89/250 count bags & 1565/30 count boxes; 114/250 count bags & 5149/30 count boxes; 67/250 count bags & 3122/30 count boxes; 35/250 count bags & 1629/30 count boxes; 305/250 count bags & 2170/30 count boxes; 99/250 count bags & 3725/30 count boxes; 1230/30 count boxes; 39/250 count bags & 1072/30 count boxes; 28/250 count bags & 344/30 count boxes; 259/250 count bags & 2502/30 count boxes; 138/250 count bags & 1192/30 count boxes; 230/250 count bags, 1860/30 count boxes, 86/60 count boxes & 18/90 count boxes; 132/250 count bags, 2714/30 count boxes, 497/60 count boxes & 155/90 count boxes; 200/250 count bags & 4527/30 count boxes; 184/250 count bags & 1259/30 count boxes; 39/250 count bags & 472/30 count boxes; 153/250 count bags & 3844/30 count boxes; 32/250 count bags & 1688/30 count boxes; 109/250 count bags & 6183/30 count boxes; 605/250 count bags, 3447/30 count boxes, 541/60 count boxes & 219/90 count boxes; 18/250 count bags & 406/30 count boxes; 123/250 count bags & 3891/30 count boxes; 1868/250 count bags & 33,853/30 count boxes; 19/250 count bags & 197/30 count boxes; 28/250 count bags & 1162/30 count boxes; 40/250 count bags & 1463/30 count bags; 181/250 count bags, 4862/30 count boxes & 147/60 count boxes; 165/250 count bags, 2693/30 count boxes, 187/60 count boxes & 23/90 count boxes; 385/30 count boxes; 100/250 count bags & 4913/30 count boxes; 214/250 count bags & 2876/30 count boxes; 664/250 count bags, 11,191/30 count boxes & 4630/60 count boxes; 87/250 count bags, 2714/30 count boxes & 7/60 count boxes; 106/250 count bags, 4669/30 count boxes & 1065/60 count boxes; 271/250 count bags, 4637/30 count boxes & 97/60 count boxes; 315/250 count bags, 4395/30 count boxes & 142/60 count boxes; 2175/30 count boxes; 260/250 count bags & 5083/30 count boxes; 4961/30 count boxes; 74/250 count bags & 3007/30 count boxes; 54/250 count bags, 4831/30 count boxes & 109/60 count boxes; 116/250 count bags & 1120/30 count boxes; 246/250 count bags, 2871/30 count boxes, 20/60 count boxes & 37/90 count boxes; 144/250 count bags, 1394/30 count boxes & 5/60 count boxes; 175/250 count bags & 3769/30 count boxes; 582/250 count bags & 3127/30 count boxes; 69/250 count bags & 1326/30 count boxes; 197/250 count bags & 3667/30 count boxes; 223/250 count bags & 6535/30 count boxes; 46/250 count bags & 1478/30 count boxes; 43/250 count bags & 1881/30 count boxes; 114/250 count bags & 2247/30 count boxes; 107/250 count bags & 1942/30 count boxes; 35/250 count bags & 155/30count boxes; 22/250 count bags & 1511/30 count boxes; 227/250 count bags & 3447/30 count boxes; 89/250 count bags & 2186/30 count boxes; 351/250 count bags & 5439/30 count boxes; 280/250 count bags & 3973/30 count boxes; 62/250 count bags & 3416/30 count boxes; 125/250 count bags, 265/30 count boxes & 750/60 count boxes; 228/250 count bags & 2068/30 count boxes; 44/250 count bags & 2459 count boxes; 50/250 count bags & 2511/30 count boxes; 61/250 count bags & 4079/30 count boxes; 42/250 count bags & 5657/30 count boxes; 137/250 count bags & 3891/30 count boxes; 96/250 count bags & 1781/30 count boxes; 40/250 count bags & 4234/30 count boxes; 174/250 count bags & 6996/30 count boxes; 32/250 count bags, 1637/30 count boxes & 597/60 count boxes; 299/250 count bags, 1976/30 count boxes & 136/60 count boxes; 100/250 count bags, 2351/30 count boxes & 50/60 count boxes; 271/250 count bags, 2536/30 count boxes, 82/60 count boxes, & 8/90 count boxes; 51/250 count bags & 912/30 count boxes; 12/250 count bags & 228/30 count boxes; 82/250 count bags & 1537/30 count boxes; 12/250 count bags & 800/30 count boxes; 1212/30 count boxes; 26/250 count bags & 1177/30 count boxes; 125/60 count bags & 355/90 count bags; 4436/30 count boxes & 182/60 count boxes; 63/250 count bags & 296/60 count boxes; 23/250 count bags & 477/30 count boxes; 250/30 count boxes & 289/60 count boxes; 148/250 count bags & 1592/30 count boxes; 65/250 count bags, 2968/30 count boxes & 282/60 count boxes; 163/250 count bags & 5952/30 count boxes; 23/250 count bags, 2363/30 count boxes & 104/60 count boxes; 53/250 count bags & 453/30 count boxes; 84/250 count bags & 4245/30 count boxes; 20/250 count bags & 699/30 count boxes; 828/250 count bags, 19,445/30 count boxes & 910/60 count boxes; 120/250 count bags & 6634/30 count boxes; 76/250 count bags & 3250/30 count boxes; 107/250 count bags & 5522/30 count boxes; 128/250 count bags, 505/30 count boxes & 613/60 count boxes; 116/250 count bags, 3679/30 count boxes & 612/60 count boxes; 23/250 count bags & 1509/30 count boxes; 13/250 count bags & 513/30 count boxes; 72/250 count bags & 4130/30 count boxes; 45/250 count bags & 4222/30 count boxes; 228/250 count bags; 82/250 count bags & 912/30 count boxes; 76/250 count bags & 1726/30 count boxes; 14/250 count bags & 481/30 count boxes; 12/250 count bags & 408/30 count boxes; 197/250 count bags, 5466/30 count boxes, 127/60 count boxes & 2/90 count boxes; 662/250 count bags, 1953/30 count boxes & 55/60 count boxes; 295/250 count bags & 3694/30 count boxes; 271/250 count bags, 6442/30 count boxes, 98/60 count boxes & 16/90 count boxes; 778/250 count bags, 2177/30 count boxes & 1356/60 count boxes; 10/250 count bags & 655/30 count boxes; 180/250 count bags & 1049/60 count boxes; 212/250 count bags & 5981/30 count boxes; 358/250 count bags, 7538/30 count boxes & 6/60 count boxes; 554/250 count bags, 12,403/30 count boxes, 92/60 count boxes & 6/90 count boxes; 112/250 count bags & 2499/30 count boxes; 163/250 count bags & 6936/30 count boxes; 176/250 count bags & 2645/30 count boxes; 479/250 count bags & 9730/30 count boxes; 231/250 count bags, 5908/30 count boxes & 516/60 count boxes; 135/250 count bags & 5010/30 count boxes; 70/250 count bags & 1188/30 count boxes; 184/250 count bags, 2365/30 count boxes, 64/60 count boxes & 88/90 count boxes; 2048/30 count boxes; 40/250 count bags & 1607/30 count boxes; 78/250 count bags & 975/30 count boxes; 36/250 count bags & 278/30 count boxes; 144/250 count bags & 2152/30 count boxes; 2796/30 count boxes & 117/90 count boxes; 342/250 count bags, 4938/30 count boxes, 52/60 count boxes & 91/90 count boxes; 162/250 count bags, 3019/30 count boxes, 70/60 count boxes & 21/90 count boxes; 204/250 count bags, 2680/30 count boxes, 35/60 count boxes, & 56/90 count boxes)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.