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Recalls affecting Wyoming

Data last updated: September 7, 2026 at 12:15 AM UTC

16,137 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled June 28, 2016

TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.

Product gives incorrect low blood glucose levels.

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Full report

FDA has not published a risk classification for this recall yet.

Recall #:
74805
Lot/product code:
Strip Lot #: PS2265 PS2283 PS2285 PS2281 PS2278 PS2276 PS2275 PS2215 PS2271 PS2279 PS2209 PS2299 PS2273 PS2274 PS2280 PS2219 PS2277 PS2268 PS2282 PS2296 PS2288 PS2284 PS2291 PS2287 PS2286 PS2297 PS2252 PS2293 PS2302 PS2292 PS2313 PS2270 PS2190 PS2189 PS2290 PS2298 PS2303 PS2289 PS2294 PS2295 PS2300 PS2304 PS2325 PS2312 PS2311 PS2305 PS2306 PS2315 PS2301 PS2314 PS2310 PS2347 PS2309 PS2318 PS2395 PS2320 PS2321 PS2316 PS2317 PS2330 PS2327 PS2324 PS2323 PS2333 PS2326 PS2328 PS2334 PS2329 PS2331 PS2332 PS2336 PS2335 PS2340 PS2345 PS2308 PS2341 PS2339 PS2307 PS2343 PS2353 PS2352 PS2338 PS2348 PS2342 PS2355 PS2344 PS2359 PS2362 PS2357 PS2349 PS2376 PS2356 PS2350 PS2367 PS2351 PS2346 PS2354 PS2371 PS2360 PS2366 PS2364 PS2370 PS2355SER PS2363 PS2319 PS2365 PS2361 PS2368 PS2372 PS2381 PS2369 PS2377 PS2392 PS2380 PS2374 PS2375 PS2373 PS2378 PS2379 PS2382 PS2380SER PS2383 PS2389 PR2068 PS2393 PS2384 PS2400 PS2391 PS2401 PS2402 PS2408 PS2388 PS2386 PS2387 PS2390 PS2385 PS2399 PS2396 PS2406 PS2398 PS2409 PS2337 PS2397 PS2404 PS2403 PS2322 PS2412 PS2416 PS2417 PS2419 PS2418 PS2420 PS2405 PS2413 PS2414 PS2394 PS2411 PS2415 PS2421 PS2267INT PS2336ILA PS2190IGB PS2267IGB PR2122INT PS2189INT PS2319INT PS2252ILA PS2345INT PS2279ILA PS2319IGB PS2407IGB PS2322IGB PS2349ITT PS2394ILA PS2307ILA PS2309ILA PS2308ILA PS2415INT PS2351ILA PS2337ILA PS2415ILA PS2411ILA PS2384ILA PS2394INT PS2413ILA PR2156INT PS2284ICA PS2316ICA PS2335ICA RS4646 RS4631 RS4649 RS4645 RS4652 RS4641 RS4653 RS4638 RS4612 RS4644 RS4655 RS4669 RS4567 RS4639 RS4605 RS4659 RS4654 RS4657 RS4608 RS4660 RS4662 RS4634 RS4676 RS4670 RS4665 RS4544 RS4674 RS4607 RS4688 RS4673 RS4667 RS4678 RS4680 RS4686 RS4677 RS4679 RS4695 RS4699 RS4703 RS4689 RS4704 RS4692 RS4694 RS4698 RS4663 RS4705 RS4708 RS4719 RS4710 RS4715 RS4717 RS4714 RS4723 RR4521 RS4716 RS4724 RS4645IGB RS4567ICA RS4704ICA DR4559 DS4648 DS4624 DS4658 DS4579 DS4672 DR4559IBR DR4559INT DS4624INT DS4648IBR DS4658INT DS4658IBR DS4624IBR DS4579IBR DS4711INT DS4672INT BS4643 BS4640 BS4650 BS4668 BS4661 BS4588 BS4651 BS4621 BS4664 BS4615 BS4675 BS4666 BS4629 BS4687 BS4681 BS4696 BS4700 BS4707 BS4693 BS4671 BS4690 BS4697 BS4701 BS4706 BS4709 BS4713 BS4720 BS4682 BS4683 BS4721 BS4643INT BS4588INT BS4697INT BS4651INT BS4629INT BS4682IAT BS4629IAT BS4602INT BS4666INT BS4682INT BS4603INT BS4671IAT. Kit Lot #: KS0967 KS1022 KS1214 KS1312 KS1154 KS1688 KS1631 KS1301 ks1133 KS1341 KS1063 KS1109 KS0968 ks1449 KS1340 KS1032 KS1266 KS1714 KS1910 KS1473 KS1546 KS1524 KS1759 KS1152 ks1108 KS1153 KS1243 KS1790 KS1763 KS1132 KS1306 KS0981 ks1323 KS1175 KS1909 KS1426 KS1215 KS1687 KS1533 KS1300 KS1643 KS1360 KS1779 KS1671 KS1933 KS1943 KS1597 KS1020 KS1417 KS1488 KS1730 KS1732 KS1496 KS1650 KS1469 KS2235 KS1501 KS1736 KS1531 KS1107 KS1580 KS1021 KS1267 KS1051 KS1646 KS1483 KS1363 KS1925 KS1659 KS0994 KS1028 KS1369 KS1627 KS1049 KS1389 KS1701 KS1053 KS1048 KS1444 KS1176 KS1364 KS0980 KS1147 KS1797 KS1957 KS1459 KS1497 KS1767 KS1311 S1700 S1700 KS1474 KS1276 KS1532 KS1792 KS1542 KS1366 KS1339 KS0988 KS1268 KS1445 ks1045 KS1447 KS1362 KS1545 KS1725 KS1692 ks1434 KS2217 KS1543 KS1031 KS1047 KS1295 KS2260 KS1764 KS1189 KS1726 KS1510 KS1278 KS2415 KS1258 KS1748 KS0996 KS1734 KS1121 KS1724 KS1187 KS1574 KS1422 KS2324 KS1365 KS1023 KS1594 KS1525 KS2373 KS1303 KS1448 KS2449 KS1534 ks1188 ks1443 KS1661 KS1930 KS2437 KS1230 KS0970ITH KS1423 KS1999ITH KS1418ITH KS1134ITH KS1229 KS1228 KS0818 KS1030ITH KS1419ITH KS1241 KS1941 KS1796 KS1954 KS1190 KS1281 KS1559 KS1489 KS1737 KS1927 KS1326 KS1560 KS1528 KS1000 KS1162 KS1453 KS1942 KS0993 KS1145 KS1944 KS1751 KS1320 KS0995 KS1441 KS1747 KS1277 KS1052 KS1599 KS1752 KS1217 KS1731 KS1013 KS1302 KS1553 KS1928 KS1186 KS1395 KS1144 KS1544 KS1487 KS1697 KS1940 KS1762 KS2414 KS1465 KS1917 KS2417 KS1468 KS1143 KS1089 KS2418 KS1116 KS1500 KS1006 KS1535 KS1704 KS1071 KS1288 KS1626 KS1628 KS2323 KS1070 KS1115 KS1446 KS0992 KS1573 KS0999 KS1705 KS1750 KS1221 KS1127 KS1567 KS1527 KS1557 KS2453 KS2971 KS1406 KS1680 KS1682 KS1056 KS1057 KS1679 KS1681 KS1684TI KS1683TI KS1786TI KS1298TI KS1042TI KS1526TI KS1988TI KS1297TI KS1787TI KS1036TI KS1041TI KS1604TI KS1177TI KS1432TI KS1603TI KS2051TI KS1135TI KS1130TI KS0921TIIBD KS1699TIIBD KS1347TI KS1348TI KS0910TI KS1346TI. Prepackaged Lot #: KS1236 KS0889 KS1670 KS1932 KS1456 KS1709 KS1250 KS1329 KS0896 KS1578 KS0948 KS1387 KS1648 ks1667 KS1736 KS1914 KS0900 KS1067 KS1665 KS0899 KS1076 KS1916 KS0946 KS1201 KS1582 KS1794 KS1197 KS1330 KS1294 KS0986 KS1309 KS1505 KS0975 KS1477 KS1262 KS1079 KS1458 KS1630 KS0891 KS1174 KS1203 KS1506 KS1663 KS1744 KS0850 KS1452TI KS1018TI KS1635TI KS1138TI KS0933TI KS1165TI KS1352TI KS1521TI KS1540TI KS1508TI KS1912TI KS1260TI KS1008TI KS0837TI KS1248TI KS1055TI KS1746TI KS1234TI KS1247TI KS0984TI KS1233TI KS1139TI KS1149TI KS1148TI.
Recalling firm:
Trividia Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2016

MOSAIQ Oncology Information System

It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
74668
Lot/product code:
Versions 2.50.05 and higher
Recalling firm:
Elekta, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 21, 2016

RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.

Sterility seal integrity failures on the Renasys Sterile Transparent Film

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
74885
Lot/product code:
Product Code 66020933 RENASYS G Small with Soft Port - Lots #'s 2015100134, 2015100313, 2015100314, 2016040686, and 2016040687 - US ONLY  Product Code 66020934 RENASYS G Medium with Soft Port - Lots #'s 2015100135, 2015100315, 2015100316, 2015110540, 2016040715, and 2016040963 US ONLY Product Code 66020935 RENASYS G Large with Soft Port- Lots #'s 2015100282, 2015100317, 2015110542, and 2016041021 US ONLY  Product Code 66020936 RENASYS G X Large with Soft Port Lot # 2016041035 US ONLY Product Code 66800394 RENASYS Transparent Film Lots #'s 2014010176, 2014011449, 2014030463, 2014040241, 2014050736, 2014051132, 2014061169, 2014113986, 2015020655, 2015040522, 2015050927, 015060209, 2015071095, 2015101044, 2015110749, 2015120664, and 2015121019 - GLOBAL Product Code 66800494 RENASYS G Medium Kit Flat Drain Lots #'s 02014P, 05014D, 06914E, 13414K, 15414T, 16014CV, 18114AV, 23214D, 25214J, and 26515H GLOBAL (NOT US) Product Code 66800495 RENASYS G Large Kit 19Fr Round Drain Lots #'s 00815K, 14014L, 23314E, 25214H, and 32214D GLOBAL (NOT US) Product Code 66800496 RENASYS G Large Kit Flat Drain Lots #'s 00815N, 01215G, 02214J, 05014F, 09014K, 09914K, 16014F, 17514T, 24114D, 25214K, 28015M, and 31714H GLOBAL (NOT US) Product Code 66800497 REANSYS G X-Large Kit 19Fr Round Drain Lot # 05014M GLOBAL (NOT US) Product Code 66800932 RENASYS High Output Fistula Kit Lots #'s 07715M, 09214H, 15514G, 18814K, and 27915G GLOBAL (NOT US) Product Code 66800933 RENASYS G Small with Soft Port Lots #'s 2014010183, 2014011414, 2014020037, 2014021119, 2014021324, 2014021837, 2014030094, 2014030840, 2014030933, 2014031770, 2014040674, 2014041232, 2014041489, 2014050297, 2014050582, 2014051447, 2014051561, 2014060367, 2014060603, 2014060606, 2014071097, 2014080670, 2014080729, 2014091593, 2014091612, 2014091896, 2014091951, 2014102569, 2014103236, 2014103501, 2014103566, 2014125085, 2014125464, 2015016495, 2015016793, 2015016824, 2015020606, 2015020633, 2015021230, 015030904, 2015030938, 2015031168, 2015050397, 2015050706, 2015051210, 2015051333, 2015060715, 2015060718, 2015060878, 2015070001, 2015070021, 2015070057, 2015070243, 2015091343, 2015100464, 2015100652, 2015100707, 2015100859, 2015100968, 2015101007, 2015120041, 2015120046, 2015120052, 2015120061, 2015120411, 2016010750, 39907, 40151, 43250, 3251, and 43252 GLOBAL (NOT US) Product Code 66800934 RENASYS G Medium with Soft Port Lots #'s 2014010306, 2014010307, 2014010965, 2014011574, 2014020362, 2014020972, 2014021207, 2014021208, 2014021930, 2014021931, 2014022059, 2014022086, 2014030302, 2014030816, 2014030934, 2014031153, 2014031404, 2014031758, 2014040175, 2014041509, 2014041510, 2014042119, 2014050158, 2014050207, 2014050345, 2014050586, 201405062, 2014051041, 2014051041, 2014060684, 2014060833, 2014061007, 2014061442, 2014061669, 2014070114, 2014070520, 2014070979, 2014071068, 2014080794, 2014080836, 2014080909, 2014090181, 2014090267, 2014091758, 2014091835, 2014092091, 2014102295, 2014102318, 2014114098, 2014114125, 2014114183, 2014114284, 2014124756, 2014124797, 2014125114, 2014125177, 2014125233, 2015020672, 2015020750, 2015020781, 2015020841, 2015021100, 2015021102, 2015031154, 2015040916, 2015050291, 2015050995, 015050996, 2015051048, 2015051382, 2015051409, 2015060395, 2015060402, 2015060912, 2015060921, 2015060979, 2015061078, 2015070313, 2015070335, 2015070348, 2015091344, 2015100024, 2015100672, 2015101328, 2015101360, 2015101522, 2015110440, 2015110767, 2015110809, 2015110931, 2015110988, 2015110989, 2015111015, 2015111261, 2015121208, 2015121237, 2016010018, 2016010772, 2016010790, 39908, 40152, 43249, 43432, 43433, 43434, 43435, and 43558 GLOBAL (NOT US) Product Code 66800935 RENASYS G Large with Soft Port Lots #s 2014010875, 2014010876, 2014010919, 2014010940, 2014011209, 2014011229, 2014011418, 2014020026, 2014020946, 2014021122, 2014021838, 2014021839, 2014022085, 2014030813, 2014030841, 2014031293, 2014031354, 2014031399, 2014040860, 2014041269, 2014041410, 2014042109, 2014042113, 2014050898, 2014051040, 2014051655, 2014060089, 2014060169, 2014060274, 2014061051, 2014061333, 2014061438, 2014080369, 2014080549, 2014090036, 014091306, 2014102445, 2014102629, 2014102650, 2014114359, 2014114527, 2014114577, 2014124708, 2014125271, 2014125307, 2014125307, 2015020993, 2015021023, 2015040809, 2015051050, 2015051077, 2015060486, 2015060493, 2015060494, 2015060507, 015061065, 2015061135, 2015061224, 2015061265, 2015070371, 2015100539, 2015100585, 2015100603, 2015100611, 2015110023, 2015110257, 2015110291, 2015110435, 2015120445, 2015120457, 2015120752, 2015120762, 2016010895, 2016011075, 39909, 40153, 43535, 43559, 43565, and 43714 GLOBAL (NOT US) Product Code 66800936 RENASYS G X Large with Soft Port Lots #'s 2014010874, 2014010961, 2014040956, 2014050897, 2014080970, 2014103611, 2015021068, 2015021444, 2015040678, 2015070796, 2015100001, 2015100272, 2015101377, and 2015120027 - GLOBAL (NOT US) Product Code 66801255 RENASYS G 10Fr Round Drain Ki… (truncated, 5591 characters total — see the official FDA record for the full value)
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled August 4, 2016

Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02

Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0218-2017
Lot/product code:
Lot # 59064DK, Exp. 11/17
Recalling firm:
Hospira Inc., A Pfizer Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 8, 2016

BD 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients.

BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.

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Full report

FDA has not published a risk classification for this recall yet.

Recall #:
75252
Lot/product code:
5355531 5355533 5356681 5356682 6006629 6006630 6006631 6006633 6006634 6006650
Recalling firm:
Becton Dickinson & Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 9, 2016

ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging

Possible injury due to movement of the arm, calibration loss and communication loss.

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Full report

FDA has not published a risk classification for this recall yet.

Recall #:
81045
Lot/product code:
Serial Numbers within U.S.A commerce - 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005, 1602006, 1602007 & 1602008   Serial Numbers Outside of U.S.A commerce - 1402005, 1402017, 1502009, 1502010, 1502011, 1302004, 1302006, 1302007, 1302008, 1302010, 1402003, 1402004, 1402010, 1402013, 1402014, 1402016, 1502008, 1602004, 1702001, 1702002, 1702003 & 1702004
Recalling firm:
Swissray Medical
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 12, 2016

Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.

Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.

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Full report

FDA has not published a risk classification for this recall yet.

Recall #:
80768
Lot/product code:
00868579000209
Recalling firm:
Ortho Kinematics, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceForeign materialRecalled August 17, 2016

HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.

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FDA has not published a risk classification for this recall yet.

Recall #:
74999
Lot/product code:
All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.
Recalling firm:
HeartWare, Inc
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled August 30, 2016

Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.

Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.

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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0118-2017
Lot/product code:
Lot #: 1136091A, Incorrectly Labeled Exp: 03/18
Recalling firm:
Actavis Laboratories, FL, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled September 27, 2016

Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Weaker than it should be Drug; Ethinyl Estradiol

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A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0122-2017
Lot/product code:
Lot Numbers: 4169952, 4169953, 4169954, 4185520, 4187127, 4190281, 4228446, 4258626, 4258627, 4279364, 4279365, 4279366, 4279369, 4359310, 4365283, 4365285, 4365286, 4365287, 4365288, 4379816, 4379817, 4479997, 4501273, 4501274, 4501275, 4563362, 4563363, 4563364, 4614359, 4614360, 4614361
Recalling firm:
Par Pharmaceutical, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled September 27, 2016

Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Weaker than it should be Drug; Ethinyl Estradiol

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0123-2017
Lot/product code:
Lot Numbers (a) 4082018, 4082019, 4359320, 4461688, 4501285, 4501286 (b) 4028921, 4258629, 4359321, 4461689, 4501287, 4581736
Recalling firm:
Par Pharmaceutical, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled September 27, 2016

Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Weaker than it should be Drug; Ethinyl Estradiol

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0121-2017
Lot/product code:
Lot Numbers: 4101072, 4101073, 4101074, 4149704, 4152054, 4152056, 4152057, 4159857, 4169950, 4169951, 4187122, 4187123, 4187124, 4187125, 4190275, 4190276, 4190278, 4190279, 4265208, 4265209, 4265210, 4265211, 4265212, 4265213, 4265214, 4265215, 4265216, 4266535, 4266536, 4266537, 4266538, 4266539, 4267686, 4267687, 4267688, 4267689, 4329888, 4334997, 4334998, 4334999, 4359303, 4359304, 4359305, 4359306, 4359307, 4359308, 4362141, 4362142, 4362143, 4362144, 4362145, 4365282, 4367923, 4367924, 4367925, 4367926, 4367927, 4367928, 4367929, 4467392, 4467393, 4467394, 4467395, 4482870, 4487638, 4501269, 4501270, 4506358, 4563356, 4563357, 4563358, 4563359, 4563360, 4563361, 4572329, 4572331, 4572332, 4572333, 4583326, 4614355, 4614356, 4614357, 4615487, 4696445, 4696446, 4698118, 4731576, 4731577, 4731578, 4731579, 4731580, 4798710, 4798711, 4798712, 4798713
Recalling firm:
Par Pharmaceutical, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled September 27, 2016

Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Weaker than it should be Drug; Ethinyl Estradiol

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0119-2017
Lot/product code:
Lot Numbers (a) 4169949, 4297235, 4359298, 4501268, 4614353 (b) 4101064, 4196576, 4228443, 4265206, 4265207, 4267685, 4365281, 4365284, 4365289, 4501276, 4563354, 4563355, 4614354, 4731574, 4731575, 4793332, 4798708, 4798709
Recalling firm:
Par Pharmaceutical, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled September 27, 2016

Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811

Weaker than it should be Drug; Ethinyl Estradiol

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0120-2017
Lot/product code:
Lot Numbers (a) 4101059, 4101062, 4190536, 4265205, 4359294, 4501265, 4572326, 4651818, 4731571, 4798704 (b) 4187113, 4187114, 4187115, 4190273, 4190274, 4190280, 4265203, 4265204, 4359296, 4367922, 4379814, 4403535, 4403536, 4501267, 4506357, 4563352, 4563353, 4572327, 4572328, 4627845, 4731572, 4731573, 4798705, 4936585
Recalling firm:
Par Pharmaceutical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 11, 2016

Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.

Lack of 510k clearance for design modification.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
75966
Lot/product code:
Model No. 66800164; All pumps of this model are affected.
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 11, 2016

Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.

Lack of 510k clearance for design modification.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
75966
Lot/product code:
Model No. 66800161 when sold separately, Model No. 66800164 when sold with RENASYS GO NPWT Pump; Serial No. < than 144500875.
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 17, 2016

TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy

Not guaranteed to be germ-free

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0318-2017
Lot/product code:
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07282016G (09/08/2016), 07082016E (08/22/2016), 07142016D (08/22/2016).
Recalling firm:
Tri-Coast Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 17, 2016

TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy

Not guaranteed to be germ-free

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0311-2017
Lot/product code:
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05132016A (07/07/2016), 07212016A (09/01/2016), 07292016B (09/08/2016), 08012016F (09/08/2016), 09072016C (09/27/2016), 11012016C (12/09/2016), 05182016E (07/02/2016), 09012016C (09/29/2016), 09272016H (11/06/2016).
Recalling firm:
Tri-Coast Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 17, 2016

BiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy

Not guaranteed to be germ-free

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0253-2017
Lot/product code:
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 09302016D (11/14/2016).
Recalling firm:
Tri-Coast Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 17, 2016

TriMix, Alprostadil/Phentolamine/Papaverine 100mcg/3mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy

Not guaranteed to be germ-free

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0320-2017
Lot/product code:
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 08022016F (12/08/2016).
Recalling firm:
Tri-Coast Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 17, 2016

Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Miacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate 200mcg/Glutamine (L) 30mg/Arginine HCL 200mg/Lidocaine HCL 10mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy

Not guaranteed to be germ-free

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0322-2017
Lot/product code:
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016B (11/19/2016), 07272016C (11/30/2016), 07152016H (11/30/2016), 09152016B (12/31/2016), 11022016B (05/01/2017), 06082016B (11/30/2016), 08172016C (12/31/2016), 10202016C (02/28/2017).
Recalling firm:
Tri-Coast Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 17, 2016

Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

Not guaranteed to be germ-free

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0282-2017
Lot/product code:
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 10262016H (12/09/2016), 11032016C (12/09/2016).
Recalling firm:
Tri-Coast Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 17, 2016

Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 ML). Compounded by Tri-Coast Pharmacy

Not guaranteed to be germ-free

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0273-2017
Lot/product code:
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016A (05/06/2016), 06282016B (07/01/2016), 06212016A (06/24/2016), 06142016A (06/17/2016), 06072016E (06/10/2016), 06022016B (06/05/2016), 06022016A (06/05/2016), 07262016H (07/29/2016), 07192016A (07/22/2016), 07122016A (07/15/2016), 07082016D (07/11/2016), 07062016B (07/09/2016), 08302016B (09/03/2016), 08232016D (08/26/2016), 08162016D (08/19/2016), 08092016E (08/11/2016), 08042016F (08/07/2016), 09272016D (09/30/2016), 09272016B (09/30/2016), 09202016A (09/23/2016), 09132016A (09/16/2016), 09072016B (09/10/2016), 10112016D (10/14/2016), 10042016B (10/07/2016), 11022016A (11/05/2016), 11092016A (11/12/2016), 11082016A (11/11/2016)
Recalling firm:
Tri-Coast Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 17, 2016

Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). Compounded by Tri-Coast Pharmacy

Not guaranteed to be germ-free

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0291-2017
Lot/product code:
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06152016C (12/12/2016), 10242016C (04/22/2017).
Recalling firm:
Tri-Coast Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 17, 2016

IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL), (30 ML). Compounded by Tri-Coast Pharmacy

Not guaranteed to be germ-free

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0265-2017
Lot/product code:
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date, if known): 05252016D (05/28/2016), 05202016A (05/23/2016), 05182016C (05/21/2016), 05092016C (05/12/2016), 05022016C (05/05/2016), 06132016D (06/16/2016), 06072016A (06/10/2016), 06062016A (06/09/2016), 07282106E (07/31/2016), 07252016G (07/28/2016), 09122016A (09/15/2016), 09192016B (09/22/2016)
Recalling firm:
Tri-Coast Pharmacy
View official FDA record (opens in a new tab)