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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Vet
Pets & Animals/Pet Medications

US Compounding Inc: Compounded Veterinary Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: March 3, 2016
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Summary

US Compounding Inc. is recalling 13,182 units of various compounded veterinary products, including injectable medications, ophthalmic ointments, and sterile solutions. The recall was initiated because the company cannot guarantee that these products are completely sterile. Consumers whose pets have received these medications should be aware that non-sterile injectable or ophthalmic products can cause serious infections or other health complications in animals.

Risk

If a medication intended to be sterile contains bacteria or other contaminants, it can cause severe infections at the site of injection or in the eyes. This lack of sterility assurance poses a moderate risk of illness or injury to animals receiving these treatments.

What You Should Do

  1. Identify if you have any of the affected medications by checking the product names and lot numbers on the vial or tube label. Key products include Acetyl-D-Glucosamine (Lot 04132015), Amikacin PF (Lot 04032015), Buprenorphine (Lot 03232015), and Cyclosporine (Lot 05052015).
  2. Check the 'Beyond Use Date' (BUD) on your product label; affected products have various dates ranging from late 2015 to early 2016.
  3. Stop using the recalled medication immediately if it matches any of the listed product names and lot numbers provided in the recall notice.
  4. Contact your veterinarian or healthcare provider immediately to discuss alternative treatment options for your pet and to report any signs of infection or adverse reactions.
  5. Return any unused portion of the medication to the pharmacy or place of purchase for a refund and contact US Compounding Inc. at their Conway, Arkansas location for further instructions.
  6. For additional questions or to report issues, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

💰Full Refund

Voluntary recall due to lack of sterility assurance.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Acetyl-D-Glucosamine 100 mL Vial (20%)
Model:
V-314-2016
Lot Numbers:
04132015@41 (BUD: 10/10/2015)
04222015@63 (BUD: 10/19/2015)
07272015@62 (BUD: 1/23/2016)
Product: Acth. Gel*R* (80 units/mL) and (40 units/mL) 10 mL
Model:
V-315-2016
Lot Numbers:
06162015@54 (BUD: 9/14/2015)
06182015@39 (BUD: 9/16/2015)
08062015@28 (BUD: 11/4/2015)
09032015@2 (BUD: 12/2/2015)
09082015@7 (BUD: 12/7/2015)
Product: Adenosine Monophosphate (200 mg/mL) 100 mL
Model:
V-316-2016
Lot Numbers:
04152015@69 (BUD: 10/12/2015)
05182015@45 (BUD: 11/7/2015)
07172015@23 (BUD: 1/13/2016)
Product: Amikacin PF 2 mL (250 mg/mL)
Model:
V-317-2016
Lot Numbers:
04032015@11 (BUD: 9/30/2015)
05192015@7 (BUD: 11/15/2015)
Product: Ammonium Chloride Sterile 10 mL Vial (5%)
Model:
V-318-2016
Lot Numbers:
03182015@23 (BUD: 9/14/2015)
04142015@7 (BUD: 10/11/2015)
05072015@17 (BUD: 11/3/2015)
06012015@60 (BUD: 11/28/2015)
06162015@7 (BUD: 12/13/2015)
06242015@64 (BUD: 12/21/2015)
07132015@19 (BUD: 1/9/2016)
07282015@125 (BUD: 1/24/2016)
09012015@81 (BUD: 2/28/2016)
Product: Ammonium Sulfate Sterile 100 mL Vial (0.75%) and (10%)
Model:
V-319-2016
Lot Numbers:
03262015@26 (BUD: 9/22/2015)
04032015@18 (BUD: 9/30/2015)
04062015@28 (BUD: 10/3/2015)
04302015@22 (BUD: 10/27/2015)
05052015@15 (BUD: 11/1/2015)
06102015@95 (BUD: 12/7/2015)
06112015@28 (BUD: 12/8/2015)
06162015@9 (BUD: 12/13/2015)
07152015@27 (BUD: 1/11/2016)
07222015@62 (BUD: 1/18/2016)
08042015@74 (BUD: 1/31/2016)
09012015@84 (BUD: 2/28/2016)
09032015@17 (BUD: 3/1/2016)
Product: Apomorphine Vials (Multiple Strengths/Sizes)
Model:
V-320-2016
Lot Numbers:
06192015@38 (BUD: 9/17/2015)
08042015@32 (BUD: 11/2/2015)
08102015@63 (BUD: 11/8/2015)
09022015@66 (BUD: 12/1/2015)
07082015@10 (BUD: 10/6/2015)
06222015@53 (BUD: 9/20/2015)
06302015@44 (BUD: 9/28/2015)
Product: Aspirin (100 mg/mL) Glass Vials
Model:
V-321-2016
Lot Numbers:
03242015@38 (BUD: 9/20/2015)
05202015@66 (BUD: 11/16/2015)
08032015@18 (BUD: 1/30/2016)
Product: Buprenorphine Sterile Vials/Syringes (0.6 mg/mL and 0.3 mg/mL)
Model:
V-329-2016
V-330-2016
Lot Numbers:
03232015@51 (BUD: 9/19/2015)
04232015@2 (BUD: 10/20/2015)
05212015@10 (BUD: 11/17/2015)
06292015@4 (BUD: 12/26/2015)
Product: Pentosan Vials (250 mg/mL) 100 mL, 50 mL, 6 mL
Model:
V-373-2016
Lot Numbers:
04292015@49 (BUD: 10/26/2015)
06242015@49 (BUD: 12/21/2015)
07152015@81 (BUD: 1/11/2016)
03182015@34 (BUD: 9/14/2015)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 72180
Status: Resolved
Manufacturer: US Compounding Inc
Sold By: Direct distribution; Veterinary clinics; Specialty pharmacies
Manufactured In: United States
Units Affected: 79 products (189 vials; 57 vials; 9 vials; 1856 vials; 250 vials; 161 vials; 356 vials; 16 vials.; 5 vials; 40 vials; 134 bottles; 10 bottles; 308 vials; 4 vials; 8 vials; 457 vials; 1047 syringes; 910 vials; 162 vials; 111 vials; 30 vials; 2 vials; 9 tubes; 8 vials; 19 tubes; 844 bottles; 30 tubes; 566 vials; 62 vials; 2 bottles; 59 vials; 3 vials; 18 tubes; 3 bottles; 14 vials; 110 vials; 523 vials; 71 bottles; 2 vials; 138 vials; 304 bags; 35 vials; 11 bottles; 10 vials; 659 vials; 22 vials; 275 vials/bottes; 476 vials; 93 vials; 94 vials; 232 vials; 60 vials; 98 tubes; 174 vials; 40 vials; 91 vials; 7 tubes; 13 vials; 2 vials; 1124 vials; 3 syringes; 3 vials; 2 vials; 30 vials; 38 vials; 1 vial; 30 vials; 126 vials; 62 vials; 1 vial; 72 vials; 13 vials; 130 vials; 159 vials; 34 vials; 3 tubes; 2 bottles; 7 vials; 43 vials)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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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