Amneal Isotretinoin Capsules Recall: Slight Tretinoin Overlevels
Amneal Pharmaceuticals recalls 10mg Isotretinoin capsules due to slightly elevated tretinoin levels. This may affect prescription strength and requires checking batch numbers.
Lower-risk recall
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Contact the company
What happened, in plain English
Amneal Pharmaceuticals is recalling 10mg Isotretinoin capsules that may have slightly elevated tretinoin levels. This could affect the medication's strength and safety for patients using prescription-only treatment. Read more at govinfonow.com/recall/37834-amneal-isotretinoin-capsules-recall-slight-tretinoin-overlevels.
Source Summary by GovInfoNow · govinfonow.com/recall/37834-amneal-isotretinoin-capsules-recall-slight-tretinoin-overlevels · Updated October 5, 2026 · FDA enforcement record: FDA #D-0321-2020
Cite this page
“Amneal Isotretinoin Capsules Recall: Slight Tretinoin Overlevels.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37834-amneal-isotretinoin-capsules-recall-slight-tretinoin-overlevels. Based on FDA recall #D-0321-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0321-2020%22&limit=1).
Why it’s dangerous
The capsules may contain slightly higher tretinoin levels than specified, which could affect the medication's strength. This might lead to inconsistent dosing but does not pose a direct safety risk like serious injury.
Who’s affected
Prescription users of Isotretinoin capsules who received batches BL10917, BL11017, or BL11117 from Amneal Pharmaceuticals. Those with the specific NDC 69238-1174-3 and expiration date 11/2019 are most at risk.
How to tell if you have this one
Check for the NDC code 69238-1174-3 and batch numbers BL10917, BL11017, or BL11117. The capsules were distributed by Amneal Pharmaceuticals with an expiration date of 11/2019.
- Brand
Amne:al- Category
Drug
What to do — step by step
Check Batch Numbers
Look for batch numbers BL10917, BL11017, or BL11117 on the blister pack.
How this recall unfolded
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0321-2020 (October 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0321-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.