Active ingredient · pooled across combinations
Penicillin G Procaine: adverse event reports, pooled
7 ingredient sets in reports · 34 FDA-approved applications in the Green Book
1,119 adverse event reports received by FDA list a drug containing penicillin g procaine, alone or in combination, from January 1987 to October 2025. This page pools every ingredient set that includes it; 7 such sets appear in reports.
The Green Book lists 34 FDA-approved applications containing it. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand.
3 reports arrived in the 12 months to March 2026, down 82% from 17 in the 12 months before. FDA posts reports quarterly with a delay of three to six months, so the newest months are incomplete and usually grow in later releases. That is about 29 reports a year over its reporting history and 0.1% of all reports.
Pooled across every set, the terms listed most often are death (24.6%), suspension, Abnormal (14.9%) and anaphylaxis (13%). Many drugs combine several ingredients, and many reports list several drugs, so a term on this page may relate to any of them or to none.
Of reports that state seriousness, 65.2% were classed as serious (38.6% across the whole database); 26.5% record a death or euthanasia (6.4% overall). Ingredients used in older or sicker animals, or in anaesthesia and cancer care, carry higher shares for that reason alone.
Ingredient sets that include penicillin g procaine
| Active ingredients recorded for the drug | Reports | Share of this page's reports | Latest 12 months |
|---|---|---|---|
| Penicillin G Procaine | 729 | 65.1% | 2 |
| Penicillin G Benzathine + Penicillin G Procaine | 310 | 27.7% | 0 |
| Novobiocin + Penicillin G Procaine | 54 | 4.8% | 0 |
| Chlorobutanol + Novobiocin + Penicillin G Procaine | 8 | 0.7% | 0 |
| Dexamethasone + Penicillin G Procaine | 7 | 0.6% | 0 |
| Dihydrostreptomycin Sulfate + Penicillin G Procaine | 7 | 0.6% | 1 |
| Hydrocortisone Acetate + Neomycin Sulfate + Penicillin G Procaine | 4 | 0.4% | 0 |
Ordered by report count. FDA states that these data "cannot be used to estimate the risk associated with the product or compare one drug or device product with another"; counts follow sales volume and years on the market. A report can list more than one set, so shares can add to more than 100%.
Signs listed in reports, pooled
share of penicillin g procaine reports listing the termall reports in the database
- Death24.6%275
- Suspension, Abnormal[a product quality report, not a sign in an animal]14.9%167
- Anaphylaxis[sudden severe allergic-type reaction]13%146
- Residues in milk6.9%77
- Injection site swelling[swelling where the injection was given]5.8%65
- Collapse5.6%63
- Injection site abscess[abscess where the injection was given]4.3%48
- Vomiting4.3%48
- Dyspnoea[difficulty breathing]3.3%37
- Ataxia[unsteady, uncoordinated movement]3.1%35
- Convulsion[seizure]2.9%33
- Injection site pain[pain where the injection was given]2.6%29
- Hyperactivity2.2%25
- Respiratory distress2.2%25
- Shaking2.1%24
- Anorexia[not eating]1.9%21
- Depression[dull, quiet or withdrawn]1.7%19
- Diarrhoea[diarrhea]1.7%19
- Fever1.7%19
- No sign[no clinical sign was reported]1.7%19
- Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]1.6%18
- Recumbency[lying down and unable or unwilling to rise]1.6%18
- Product Defect, General[a product quality report, not a sign in an animal]1.5%17
- Mammary gland oedema1.4%16
- Urticaria[hives]1.4%16
- Accidental exposure[exposure that was not intended]1.3%15
- Hypersalivation[drooling]1.3%15
- Restlessness1.3%15
- Trembling1.3%15
- Vials, Damaged[a product quality report, not a sign in an animal]1.3%15
Pooled across every ingredient set and every report that names the ingredient. One report can list several terms and several drugs; a term here may relate to any of them or to none.
Monthly reports by species, five years
By month of receipt; each panel has its own scale. The newest months are incomplete because FDA posts reports with a delay of three to six months.
Outcomes, report types and ages
Outcome recorded in the report
What kind of report it was
Age of the animal
Coloured bar: reports naming penicillin g procaine. Grey bar: all 1,357,245 reports. Outcomes are as stated by the reporter; FDA has not necessarily determined whether any product played a part.
In context
| Measure | Penicillin G Procaine | All reports |
|---|---|---|
| Reports | 1,119 | 1,357,245 |
| Latest 12 months against the 12 before | -82% | -5% |
| Classed serious, of reports stating it | 65.2% | 38.6% |
| Death or euthanasia recorded, per 1,000 reports | 265.4 | 63.8 |
| Filed as lack of expected effectiveness (wholly or partly) | 0.5% | 23% |
Shares of reports, not of animals treated: how many animals receive the ingredient is not public. Ingredients used in anaesthesia, cancer care or in old animals carry more serious outcomes in their reports for that reason alone.
FDA-approved products containing penicillin g procaine (Green Book)
Reference information, not report statistics. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The list below is the FDA Green Book as of 1 Oct 2026; nothing on this page says which of these products, if any, a report concerned.
| Trade name | Active ingredients | Sponsor | Approved for | Application |
|---|---|---|---|---|
| Quartermaster Suspension | Dihydrostreptomycin Sulfate, Penicillin G Procaine | HQ Specialty Pharma Corp. | Cattle | NADA 055-028 |
| Albacillin Suspension; Special Formula 17900-Forte Suspension | Novobiocin Sodium, Penicillin G Procaine | Zoetis Inc. | Cattle | NADA 055-072 |
| Dry-Mast | Dihydrostreptomycin Sulfate, Penicillin G Procaine | HQ Specialty Pharma Corp. | Cattle | NADA 055-097 |
| Albadry Plus Suspension | Novobiocin Sodium, Penicillin G Procaine | Zoetis Inc. | Cattle | NADA 055-098 |
| Norocillin | Penicillin G Procaine | Norbrook Laboratories, Ltd. | Horses, Cattle, Swine, Sheep | NADA 065-010 |
| Go-dry; MASTI-CLEAR | Penicillin G Procaine | HQ Specialty Pharma Corp. | Cattle | NADA 065-081 |
| Longicil Fortified | Penicillin G Benzathine, Penicillin G Procaine | Zoetis Inc. | Cattle | NADA 065-087 |
| Pen-G Max | Penicillin G Procaine | Huvepharma EOOD | Dogs, Cats, Horses, Cattle, Swine, Sheep | NADA 065-110 |
| Forte Topical Ointment | Hydrocortisone Acetate, Neomycin Sulfate, Penicillin G Procaine, Polymyxin B Sulfate | Zoetis Inc. | Dogs, Cats | NADA 065-119 |
| Crystalline Pro Penicillin G | Penicillin G Procaine | Zoetis Inc. | Dogs, Cats, Horses | NADA 065-130 |
| Dura-Biotic; Flo-cillin | Penicillin G Benzathine, Penicillin G Procaine | Zoetis Inc. | Dogs, Horses, Cattle | NADA 065-169 |
| Crysticillin 300 A.S. | Penicillin G Procaine | Zoetis Inc. | Dogs, Cats, Horses, Cattle, Swine, Sheep | NADA 065-174 |
| Formula A-34; Uni-Biotic 4 Dose; Herdsman’s Choice; Dry-A-Cillin | Penicillin G Procaine | Bimeda Animal Health Ltd. | Cattle | NADA 065-383 |
| Dual-Cillin; Pen BP-48 | Penicillin G Benzathine, Penicillin G Procaine | Huvepharma EOOD | Cattle | NADA 065-498 |
| Pro-Pen-G | Penicillin G Procaine | Bimeda Animal Health Ltd. | Horses, Cattle, Swine, Sheep | NADA 065-505 |
| Combi-Pen-48 | Penicillin G Benzathine, Penicillin G Procaine | Bimeda Animal Health Ltd. | Cattle | NADA 065-506 |
| Bonaid & Zinc Bacitracin & Penicillinapproval voluntarily withdrawn | Bacitracin Zinc, Buquinolate, Penicillin G Procaine | Proctor & Gamble Pharmaceuticals, Inc. | — | NADA 035-315 |
| Bonaid & Penicillinapproval voluntarily withdrawn | Buquinolate, Penicillin G Procaine | Proctor & Gamble Pharmaceuticals, Inc. | — | NADA 035-317 |
| Bonaid & Bacitracin MD & Penapproval voluntarily withdrawn | Bacitracin methylenedisalicylate, Buquinolate, Penicillin G Procaine | Proctor & Gamble Pharmaceuticals, Inc. | — | NADA 035-327 |
| CSP 250; CSP 500approval voluntarily withdrawn | Chlortetracycline Hydrochloride, Penicillin G Procaine, Sulfathiazole | Zoetis Inc. | Swine | NADA 039-077 |
| Penicillin 100 Type A Medicated Article; Penicillin G Procaine 50 Type A Medicated Articleapproval voluntarily withdrawn | Penicillin G Procaine | Zoetis Inc. | Swine, Chickens, Turkeys | NADA 046-666 |
| Penicillin G Procaine 50% Type A Medicated Articleapproval voluntarily withdrawn | Penicillin G Procaine | Phibro Animal Health Corp. | Swine, Chickens, Turkeys | NADA 046-668 |
| Rainbrook Broiler Premix No.1approval voluntarily withdrawn | Amprolium, Arsanilic Acid, Ethopabate, Penicillin G Procaine, Streptomycin | Stockton Hay & Grain Co. | Chickens | NADA 049-462 |
| Bicillin Fortifiedapproval voluntarily withdrawn | Penicillin G Benzathine, Penicillin G Procaine | Wyeth Laboratories | Dogs, Horses, Cattle | NADA 055-008 |
| Aqua-Mast; Hanfords Four-Penapproval voluntarily withdrawn | Penicillin G Procaine | G.C. Hanford Mfg. Co. | Cattle | NADA 065-465 |
| True Antibiotic Formula #10approval voluntarily withdrawn | Penicillin G Procaine | Boehringer Ingelheim Animal Health USA Inc. | — | NADA 065-466 |
| Benza-Penapproval voluntarily withdrawn | Penicillin G Benzathine, Penicillin G Procaine | Walco International, Inc. | Dogs, Horses, Cattle | NADA 065-488 |
| Jetpen; Penicillin G Procaine Aqueous Suspensionapproval voluntarily withdrawn | Penicillin G Procaine | Norbrook Laboratories, Ltd. | Horses, Cattle, Swine, Sheep | NADA 065-493 |
| Tandem Penapproval voluntarily withdrawn | Penicillin G Benzathine, Penicillin G Procaine | Norbrook Laboratories, Ltd. | Dogs, Horses, Cattle | NADA 065-500 |
| Chlorachel 250 Swine; Pficlor 1000; Pficlor 250; Pficlor-SP 250approval voluntarily withdrawn | Chlortetracycline Calcium Complex, Penicillin G Procaine, Sulfamethazine | Zoetis Inc. | Swine | NADA 091-668 |
| Nicarbazin plus Penicillin G Procaine plus 3-Nitroapproval voluntarily withdrawn | Nicarbazin, Penicillin G Procaine, Roxarsone | Phibro Animal Health Corp. | Chickens | NADA 098-371 |
| Nicarbazin plus Penicillin G Procaineapproval voluntarily withdrawn | Nicarbazin, Penicillin G Procaine | Phibro Animal Health Corp. | Chickens | NADA 098-374 |
| Aureozolapproval voluntarily withdrawn | Chlortetracycline Hydrochloride, Penicillin G Procaine, Sulfathiazole | Zoetis Inc. | Swine | ANADA 200-140 |
| Aureozol 500 Granularapproval voluntarily withdrawn | Chlortetracycline Calcium Complex, Penicillin G Procaine, Sulfathiazole | Zoetis Inc. | Swine | ANADA 200-167 |
Species are the major species the Green Book search lists for the application ("—" where it lists another species or none). Approval dates are not part of the Green Book listing files and are not shown. Pioneer applications (NADA) come first, then generics (ANADA).
Questions about penicillin g procaine reports
How many FDA adverse event reports mention penicillin g procaine?
1,119 reports through March 2026, 3 of them in the latest 12 months, counting penicillin g procaine alone and in combinations.
Which brands do these reports concern?
That cannot be known from the public data. openFDA masks brand and manufacturer names in adverse event records, so the reports counted here cannot be attributed to a particular brand. The Green Book reference list on this page names approved products containing penicillin g procaine without any counts.
In which combinations is penicillin g procaine reported?
Penicillin G Procaine (65.1% of these reports), Penicillin G Benzathine + Penicillin G Procaine (27.7% of these reports), Novobiocin + Penicillin G Procaine (4.8% of these reports), Chlorobutanol + Novobiocin + Penicillin G Procaine (0.7% of these reports) and Dexamethasone + Penicillin G Procaine (0.6% of these reports).
What reactions are reported for penicillin g procaine?
death (24.6%), suspension, Abnormal (14.9%), anaphylaxis (13%), residues in milk (6.9%) and injection site swelling (5.8%). Shares are of reports naming the ingredient; one report can list several terms.
Which animals are these reports about?
cattle (25.6%), dog (16.3%) and horse (15.1%).
Does a high count mean penicillin g procaine is a problem ingredient?
A count cannot show that. FDA states that "there is no certainty that the reported drug or device caused the adverse event" and that the event "may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources." Widely used ingredients collect more reports because more animals receive them.
How do I report a problem?
Call the drug company using the number on the label, or send Form FDA 1932a to FDA. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Animal & Veterinary adverse event bulk files released 28 Sep 2026, which hold reports FDA's Center for Veterinary Medicine received through 31 Mar 2026. openFDA masks brand and manufacturer names in these files, so drugs are counted by the active ingredients each record discloses and no figure is attributed to a brand, application or company. Ingredient names, and the separate reference lists of approved products, follow the FDA Green Book as of 1 Oct 2026. Ingredient names follow the Green Book; salts and forms are kept as FDA lists them. Drug entries are matched by the active ingredients their unmasked ingredient field discloses. No report text, lot numbers or reporter details are published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.