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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: Misoprostol Veterinary Suspensions and Pastes Recalled for Low Potency

Agency Publication Date: November 12, 2015
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Summary

US Compounding Inc. is recalling 38,290 units of Misoprostol veterinary products, including various oral suspensions and pastes, because they are sub-potent. The medication was formulated using a 1% diluted active ingredient instead of the intended 99% potency ingredient, meaning the finished medicine contains significantly less active drug than required for treatment. These compounded veterinary products were distributed in 11 states and include both 2 mg/5 mL and 1.4 mg/10 mL suspensions, as well as several concentrations of Misoprostol pastes in 30 mL and 60 mL containers.

Risk

Because the medication is significantly weaker than intended, it will not provide the necessary therapeutic effect for the animal. This sub-potency can lead to treatment failure for the underlying condition the Misoprostol was prescribed to manage.

What You Should Do

  1. Immediately check your veterinary medication labels for Misoprostol (F.O.B.) 2 mg/5 mL or 1.4 mg/10 mL Oral Suspensions (NDC 22200899801, 22200894701) with lot numbers 03182015@32, 03312015@36, 04162015@5, 05082015@3, 07072015@67, or 03262015@38.
  2. Check your veterinary medication labels for Misoprostol 30 mL or 60 mL Pastes (NDC 22200894630, 22200880730, 22200893660, 22200579460, 22200617260) with lot numbers including 03042015@1, 03232015@11, 03262015@1, 06102015@64, 01062015@30, 01082015@41, 02202015@44, 04242015@52, 02262015@1, 04022015@33, 04072015@3, 06092015@30, 06102015@4, 07062015@1, 07132015@65, 01222015@23, 01222015@25, 01282015@12, 02182015@39, or 03232015@23.
  3. Contact your veterinarian or pharmacist immediately to discuss alternative treatment options and to confirm if your specific batch is affected.
  4. Return any unused portions of the recalled medication to the pharmacy where it was dispensed for a refund and to ensure proper disposal.
  5. Contact US Compounding Inc. directly at their Conway, Arkansas location for further instructions regarding this voluntary recall.
  6. For additional questions, you may contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: Misoprostol (F.O.B.) 2 mg/5 mL oral Suspension
Model:
NDC: 22200899801
Lot Numbers:
03182015@32
03312015@36
04162015@5
05082015@3
07072015@67
03262015@38
Product: Misoprostol (F.O.B) 1.4 mg/10 mL Suspension
Model:
NDC: 22200894701
Lot Numbers:
03182015@32
03312015@36
04162015@5
05082015@3
07072015@67
03262015@38
Product: Misoprostol 30 mL 1.4 mg/10 mL Paste
Model:
NDC: 22200894630
Lot Numbers:
03042015@1
03232015@11
03262015@1
06102015@64
01062015@30
01082015@41
02202015@44
04242015@52
02262015@1
04022015@33
04072015@3
06092015@30
06102015@4
07062015@1
07132015@65
01222015@23
01222015@25
01282015@12
02182015@39
03232015@23
Product: Misoprostol 30 mL 1.4 mg/mL Paste
Model:
NDC: 22200880730
Lot Numbers:
03042015@1
03232015@11
03262015@1
06102015@64
01062015@30
01082015@41
02202015@44
04242015@52
02262015@1
04022015@33
04072015@3
06092015@30
06102015@4
07062015@1
07132015@65
01222015@23
01222015@25
01282015@12
02182015@39
03232015@23
Product: Misoprostol 60 mL 1.4 mg/10 mL Paste
Model:
NDC: 22200893660
Lot Numbers:
03042015@1
03232015@11
03262015@1
06102015@64
01062015@30
01082015@41
02202015@44
04242015@52
02262015@1
04022015@33
04072015@3
06092015@30
06102015@4
07062015@1
07132015@65
01222015@23
01222015@25
01282015@12
02182015@39
03232015@23
Product: Misoprostol 60 mL 1.6 mg/30 mL Paste
Model:
NDC: 22200579460
Lot Numbers:
03042015@1
03232015@11
03262015@1
06102015@64
01062015@30
01082015@41
02202015@44
04242015@52
02262015@1
04022015@33
04072015@3
06092015@30
06102015@4
07062015@1
07132015@65
01222015@23
01222015@25
01282015@12
02182015@39
03232015@23
Product: Misoprostol 60 mL 1.6 mg/5 mL Paste
Model:
NDC: 22200617260
Lot Numbers:
03042015@1
03232015@11
03262015@1
06102015@64
01062015@30
01082015@41
02202015@44
04242015@52
02262015@1
04022015@33
04072015@3
06092015@30
06102015@4
07062015@1
07132015@65
01222015@23
01222015@25
01282015@12
02182015@39
03232015@23

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 71947
Status: Resolved
Manufacturer: US Compounding Inc
Sold By: US Compounding Inc
Manufactured In: United States
Units Affected: 2 products (2350 containers; 35940 containers)
Distributed To: Florida, Kentucky, Maryland, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Texas, Wisconsin, West Virginia

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 ยท Raw API Response