UnratedDrug recall · FDA · Published September 15, 2021
American Health Packaging Valproic Acid Oral Solution Recall: Microbial Contamination Risk
American Health Packaging recalls Valproic Acid Oral Solution due to potential microbial contamination in some batches. This medication is prescription-only and may pose health risks if consumed. Consumers should check their product details and contact the manufacturer for guidance.
“American Health Packaging Valproic Acid Oral Solution Recall: Microbial Contamination Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35854-american-health-packaging-valproic-acid-oral-solution-recall-microbial-contamination. Based on FDA recall #D-0854-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0854-2021%22&limit=1).
The FDA announced on September 15, 2021, that American Health Packaging is recalling Valproic Acid Oral Solution due to potential microbial contamination from liquid sugar batches. The agency classified the recall as Class II.
How to tell if you have it
Brand: American Health Packaging
Product: Valproic Acid Oral Solution, USP, 500 mg/10 mL
Packaging: 100 10 mL unit dose cups per case
Case NDC#: 60687-262-56
Individual Dose NDC: 60687-262-42
Lot code: 1000082
Expiration date: 06/30/2022
Quantity: 548 cases
The hazard
The recall cites CGMP deviations involving potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms. The FDA reported no specific incidents or injuries in this record.
Context
GovInfoNow's records show American Health Packaging has 41 other recalls on record since July 23, 2012. Other recent recalls of similar products include American Health Packaging Buprenorphine Tablets Recall (August 19, 2026), American Health Packaging Nitrofurantoin Capsules Recall (May 3, 2022), and American Health Packaging Recalls Cyanocobalamin Injection Due to Subpotent Drug (April 12, 2022). Other recent recalls of similar products include American Regent ACETYLCYSTEINE Solution Recall (July 24, 2026), Zep Alcohol Sanitizer Spray Recall (May 22, 2026), and BD PurPrep Sterile Solution Recall (April 22, 2026).
How to tell if you have this one
Check for the lot number 1000082 and expiration date 06/30/2022 on the product label. The product is a prescription-only oral solution with 500 mg/10 mL concentration, sold in 100 unit dose cups per case.
Brand
American Health Packaging
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number 1000082 and expiration date 06/30/2022 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0854-2021 (September 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0854-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.