Attix Pharmaceuticals Recalls Pregabalin Ingredient Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling pregabalin active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant harm (penicillin cross-contamination) align with a Severe rating, particularly given the risk to penicillin-allergic individuals.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of pregabalin active pharmaceutical ingredient (API) that were repackaged and distributed between January 5, 2012, and February 12, 2015. The product is packaged in varying grams or kilograms in bags or drums. The recall involves 2,900 grams of the ingredient.
The recall is being conducted because the product was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates a potential for cross-contamination with penicillin. The affected product was distributed nationwide to compounding pharmacies and research organizations.
Consumers and healthcare providers should stop using the affected pregabalin API and contact their supplier or the recalling firm for instructions on return or disposal. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Pregabalin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
- Manufacturer
- Attix Pharmaceuticals
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots repackaged and distributed between 01/05/12 to 02/12/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 470 recalled by Attix Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 470 products in this recall →Related recalls
Same manufacturer · Attix Pharmaceuticals
See all →- SevereAttix Pharmaceuticals Recalls Idebenone Due to Penicillin Cross Contamination Risk
FDA (Drugs) · 2015-04-29
- SevereAttix Pharmaceuticals Recalls Methylprednisolone Base Due to Penicillin Cross-Contamination Risk
FDA (Drugs) · 2015-04-29
- SevereCarbazochrome API Recalled for Potential Penicillin Cross Contamination
FDA (Drugs) · 2015-04-29
- SevereAttix Pharmaceuticals Recalls Cidofovir Dihydrate Due to Penicillin Cross-Contamination Risk
FDA (Drugs) · 2015-04-29
- SevereAttix Pharmaceuticals Recalls Pheniramine Maleate Due to Penicillin Cross-Contamination Risk
FDA (Drugs) · 2015-04-29
Same hazard · cross contamination
See all →- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29
- ModeratePrimidone tablets recalled over potential acemetacin cross-contamination at API manufacturer
FDA (Drugs) · 2026-06-17
- HighFly By Jing creamy sesame noodles may contain undeclared peanut
FDA (Food) · 2026-06-03
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets 50 mg Recalled for API Cross-Contamination
FDA (Drugs) · 2026-05-27