Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

11701–11725 of 17987

SevereFDA (Drugs)·D-1405-2016·2016-07-27
FDA Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 2,006 bags of compounded fentanyl and bupivacaine injectable drugs because the active ingredient was contaminated with glass particulate matter.
Product
2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1366-2016·2016-07-27
PharMEDium Recalls Bupivacaine HCl Cassettes Due to Glass Particulate
PharMEDium Services, LLC is recalling 315 cassettes of 0.15% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1423-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 3,474 bags of sterile injectable fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate.
Product
5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1413-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 700 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1421-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulates
Pharmedium Services is recalling 2,256 cassettes of compounded Fentanyl and Bupivacaine because glass particulates were found in the active ingredient.
Product
5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1407-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 380 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8297, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-297-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1410-2016·2016-07-27
Pharmedium Recalls Sterile Injectable Drugs Contaminated With Glass Particulate Matter
Pharmedium Services, LLC is recalling 25 bags of compounded sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8494, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-494-61
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1430-2016·2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated With Glass Particulate
PharMEDium Services is recalling 90 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8233, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-233-54
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1395-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services, LLC is recalling 43,589 bags of sterile injectable fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 250 ml Cormix Bag ; Service Code 2H8131 , NDC 61553-131-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8201 , NDC…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1432-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
Pharmedium Services, LLC is recalling 180 syringes of compounded Fentanyl Citrate and Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-993-86
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1386-2016·2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate
PharMEDium Services, LLC is recalling 1,234 cassettes of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1414-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 345 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.
Product
3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1401-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 90 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1428-2016·2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter
PharMEDium Services, LLC is recalling 115 bags of compounded sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1380-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Injectable Due to Glass Particulate
Pharmedium Services, LLC is recalling specific lots of compounded Fentanyl Citrate and Bupivacaine HCl injectable solutions because they were produced using an API contaminated with glass particulate matter.
Product
10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1429-2016·2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate
PharMEDium Services, LLC is recalling 445 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only, Compounded by…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1377-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
PharMEDium Services, LLC is recalling 384 cassettes of Fentanyl Citrate and Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1362-2016·2016-07-27
PharMEDium Recalls Bupivacaine HCl Due to Glass Particulate Contamination
PharMEDium Services, LLC is recalling 2,194 bags and cassettes of 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride because the active pharmaceutical ingredient was contaminated with glass particulate matter.
Product
0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1371-2016·2016-07-27
PharMEDium Recalls Sufentanil and Bupivacaine Cassettes Due to Glass Particulates
PharMEDium Services is recalling 325 cassettes of compounded sufentanil and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1375-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services is recalling 1,527 bags of compounded fentanyl and bupivacaine injectable solution because glass particulate was found in the active pharmaceutical ingredient.
Product
1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1381-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate
Pharmedium Services is recalling specific lots of compounded fentanyl and bupivacaine syringes because the active ingredient was contaminated with glass particulate matter.
Product
10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1389-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulates
PharMEDium Services is recalling 425 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.
Product
2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8103, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-103-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1360-2016·2016-07-27
Pharmedium Recalls Bupivacaine HCl Due to Glass Particulate Contamination
Pharmedium Services, LLC is recalling 177 cassettes of 0.03% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1419-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
Pharmedium Services is recalling 3,828 syringes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1367-2016·2016-07-27
PharMEDium Recalls Bupivacaine HCl Due to Glass Particulate Contamination
PharMEDium Services, LLC is recalling 355 bags of 0.2% Bupivacaine HCl sterile injectable drugs because the active ingredient was contaminated with glass particulate matter.
Product
0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463…
Category
Drug
Distribution
Distributed nationwide

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11701–11725 of 17987