American Health Packaging recalls Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by:
American Health Packaging recalls 0.125 mg Pramipexole tablets with possible cross contamination from cleaning failures. Consumers should check NDC numbers and lot dates for affected batches.
Lower-risk recall
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Contact the company & request your remedy
What happened, in plain English
American Health Packaging is recalling Pramipexole Dihydrochloride tablets (0.125 mg) due to possible cross contamination from cleaning procedure failures. This could affect people taking this medication for movement disorders. Read more at govinfonow.com/recall/38817-american-health-packaging-recalls-pramipexole-tablets-due-to-possible-cross.
Source Summary by GovInfoNow · govinfonow.com/recall/38817-american-health-packaging-recalls-pramipexole-tablets-due-to-possible-cross · Updated October 5, 2026 · FDA enforcement record: FDA #D-1431-2019
Cite this page
“American Health Packaging recalls Pramipexole tablets due to possible cross contamination.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38817-american-health-packaging-recalls-pramipexole-tablets-due-to-possible-cross. Based on FDA recall #D-1431-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1431-2019%22&limit=1).
Why it’s dangerous
The recall is for possible cross contamination of the product due to cleaning procedure failures in the manufacturing process. This could mean the medication is contaminated with other substances.
Who’s affected
People prescribed Pramipexole Dihydrochloride tablets for movement disorders. Those with specific NDC numbers and lot dates listed in the recall are most at risk.
How to tell if you have this one
Check for NDC Blister Card: 68084-793-95 or NDC Carton: 68084-793-25. The affected lots are Lot 179049 (expiring 12/31/2019) and Lot 182571 (expiring 8/31/2020).
- Brand
American Health Packaging- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1431-2019 | Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25; Lot, expiry: Lot 179049, exp 12/31/2019; Lot 182571, exp 8/31/2020 | 3,015 cartons |
| D-1432-2019 | Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01; Lot, expiry: Lot 172669, exp 05/31/2019; Lots 175872, 177086, exp 09/30/2019; Lot 179047, exp 12/31/2019; Lot 182584, exp 07/31/2020 | 16,698 cartons |
| D-1433-2019 | Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-974-95; NDC Carton: 68084-974-25; Lot, expiry: Lots 175820, 176569, exp 09/30/2019; Lots 177866, 179627A, 179627B, exp 12/31/2019; Lot 181627, exp 06/30/2020 | 8,777 cartons |
| D-1434-2019 | Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25; Lot, expiry: Lot 176179, exp 05/31/2019; Lot 176616, exp 07/31/2019; Lot 178562, exp 09/30/2019; Lot 179947, exp 12/31/2019; Lot 182048, exp 04/30/2020; Lot 183136, exp 06/30/2020; Lot 184217, exp 08/31/2020 | 6,643 cartons |
What to do — step by step
Check Product Details
Look for NDC Blister Card 68084-793-95 or NDC Carton 68084-793-25 on the packaging.
Questions people ask
Is this product safe to use?
The recall states possible cross contamination from cleaning failures, but the product is still safe to use if it's not in the affected lots.
How do I know if my product is affected?
Check for NDC Blister Card 68084-793-95 or NDC Carton 68084-793-25 with lot numbers 179049 (exp 12/31/2019) or 182571 (exp 8/31/2020).
What should I do if I have the affected product?
The recall does not specify a remedy, so contact American Health Packaging for further instructions.
Contact American Health Packaging
We’ve drafted a message you can send American Health Packaging to request your refund or repair — edit it as you like.
Subject: Recall D-1431-2019 — American Health Packaging American Health Packaging Hello, I own a American Health Packaging that is covered by recall D-1431-2019 from American Health Packaging. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1431-2019 (May 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1431-2019 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.