The Recall Desk

Hazard

Sterility recalls

2,384 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,384
Critical
1
Severe
2,114
Most recent
2026-09-09

Of the 2,384 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,114 (89%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1851–1875 of 2384

  • SevereFDA (Drugs)·D-1386-2015·2015-09-02

    Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Papaverine/Phentolamine/PGE-1 Injectable vials because process deficiencies could have compromised the product's sterility.

    Product
    Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1381-2015·2015-09-02

    Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Papaverine/Phentolamine/PGE-1 Injectable vials because process deficiencies may have compromised sterility.

    Product
    Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1349-2015·2015-08-26

    Bausch & Lomb Recalls Bromfenac Ophthalmic Solution Due to Sterility Concerns

    Bausch & Lomb is recalling 13,995 bottles of Bromfenac Ophthalmic Solution, 0.09%, because preservative testing failed, raising concerns about sterility.

    Product
    Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1295-2015·2015-08-12

    Apothecary Shoppe Recalls Papaverine and Phentolamine Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling specific vials of Papaverine and Phentolamine Injection due to a lack of documentation confirming proper environmental monitoring during production.

    Product
    SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1296-2015·2015-08-12

    Apothecary Shoppe Recalls Papaverine and Phentolamine Injection Due to Sterility Concerns

    The Apothecary Shoppe is recalling specific lots of SIU-Papav/Phentol 30/1 mg/mL Injection due to a lack of documentation for environmental monitoring during production.

    Product
    SIU-Papav/Phentol 30/1 mg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1297-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Phent Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIU-Phent .4 mg/PGE1 20 mcg/mL Injection due to a lack of documentation for environmental monitoring during production.

    Product
    SIU-Phent .4 mg/PGE1 20 mcg/mL Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1802-97
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1293-2015·2015-08-12

    Apothecary Shoppe Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    The Apothecary Shoppe is recalling specific lots of Testosterone Cypionate Injection due to a lack of documentation confirming proper environmental monitoring during production.

    Product
    SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1312-2015·2015-08-12

    Apothecary Shoppe Recalls SO-Acetylcysteine Ophthalmic Solution for Sterility Concerns

    The Apothecary Shoppe LLC is recalling SO-Acetylcysteine 10% Sterile Ophthalmic Solution due to lack of documentation for environmental monitoring during production.

    Product
    SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1313-2015·2015-08-12

    Apothecary Shoppe Recalls Prostaglandin E1 Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIU-Prostaglandin E1 500 mcg/mL Injection vials in Oklahoma due to lack of documentation for environmental monitoring during production.

    Product
    SIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1289-2015·2015-08-12

    Apothecary Shoppe Recalls S-Methylcobalamin Injection Due to Sterility Concerns

    The Apothecary Shoppe is recalling S-Methylcobalamin 1000 mcg/mL Injection because documentation for environmental monitoring during production was missing.

    Product
    S-Methylcobalamin 1000 mcg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1962-40
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1291-2015·2015-08-12

    Apothecary Shoppe Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIH-Testosterone Cypionate Injection because proper environmental monitoring documentation is missing, raising concerns about sterility.

    Product
    SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1306-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Due to Sterility Documentation Issues

    The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 20/1 mg/10 mcg/mL vials because proper environmental monitoring documentation was missing during production.

    Product
    SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2913-85
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1314-2015·2015-08-12

    Apothecary Shoppe Recalls Phentolamine Vials Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIU-Phentolamine 5 mg/mL vials in Oklahoma due to lack of documentation for environmental monitoring during production.

    Product
    SIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1300-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Phent Injection Due to Sterility Documentation Issues

    The Apothecary Shoppe is recalling SIU-Phent .8/PGE1 20 mcg/mL Injection vials because proper environmental monitoring documentation was missing during production.

    Product
    SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1308-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/1/10 Injection vials in Oklahoma due to a lack of documentation for environmental monitoring during production.

    Product
    SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1316-2015·2015-08-12

    Apothecary Shoppe Recalls S-Methylcobalamin Injection Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling S-Methylcobalamin 5000 mcg/mL Injection in 750 mL containers due to a lack of assurance of sterility.

    Product
    S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1303-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns

    The Apothecary Shoppe is recalling SIU-Tri-Mix 18/1/20 Injection because documentation for environmental monitoring during production was missing.

    Product
    SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1310-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Due to Sterility Documentation Gaps

    The Apothecary Shoppe is recalling SIU-Tri-Mix vials because documentation for environmental monitoring during production was missing, raising concerns about sterility.

    Product
    SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13389-1152-36
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1299-2015·2015-08-12

    Apothecary Shoppe Recalls Papaverine and Phentolamine Injection Due to Sterility Concerns

    The Apothecary Shoppe is recalling specific vials of Papaverine and Phentolamine Injection because documentation for environmental monitoring during production was missing.

    Product
    SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-1775-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1298-2015·2015-08-12

    Apothecary Shoppe Recalls Papaverine and Phentermine Injection for Sterility Concerns

    The Apothecary Shoppe LLC is recalling specific vials of Papaverine and Phentermine Injection due to a lack of documentation proving proper environmental monitoring during production.

    Product
    SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1315-2015·2015-08-12

    Apothecary Shoppe Recalls Hydroxyprogesterone Caproate Vials for Sterility Concerns

    The Apothecary Shoppe is recalling Hydroxyprogesterone Caproate 250 vials due to lack of documentation for environmental monitoring during production.

    Product
    SIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1311-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Injectable Due to Sterility Concerns

    The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/1/20 Injectable in Oklahoma due to a lack of documentation ensuring proper environmental monitoring during production.

    Product
    SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1290-2015·2015-08-12

    Apothecary Shoppe Recalls HCG Injection Due to Sterility Documentation Issues

    The Apothecary Shoppe is recalling HCG 1000 U/mL Injection vials because proper environmental monitoring documentation was missing during production.

    Product
    S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 14294-1968-80
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1307-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns

    The Apothecary Shoppe is recalling SIU-Tri-Mix 24/1/20 Injection vials because documentation for environmental monitoring during production was missing, raising concerns about sterility.

    Product
    SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1747-39
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1304-2015·2015-08-12

    Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns

    The Apothecary Shoppe is recalling SIU-Tri-Mix Injection Solution because proper environmental monitoring documentation was missing during production.

    Product
    SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70
    Category
    Drug
    Distribution
    1 state