Freedom Pharmaceuticals Recalls Baclofen Powder Due to Foreign Substance
Freedom Pharmaceuticals is recalling specific lots of Baclofen USP powder because of the presence of a foreign substance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a drug product with a foreign substance hazard where no specific injuries or illnesses are reported in the source text, fitting the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Freedom Pharmaceuticals Inc is recalling specific lots of Baclofen USP powder. The recall is being conducted due to the presence of a foreign substance in the product.
The affected product is packaged in 25gm, 100gm, 500gm, and 1000gm containers. The specific lots involved are F10918, F10918-2, F10867, and F10867A. The distribution pattern for these products was nationwide.
Consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d)…
- Manufacturer
- Freedom Pharmaceuticals Inc
- Category
- Drug — Powder
- Hazard
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 (6)
- Lot #: F10918
- F10918-2
- Exp: 07/24/2016
- F10867
- F10867A
- Exp date: 03/11/2016
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Freedom Pharmaceuticals Inc
See all →- HighFreedom Pharmaceuticals Recalls Domperidone API Due to Penicillin Cross-Contamination
FDA (Drugs) · 2016-01-20
- LowFreedom Pharmaceuticals Recalls Subpotent 5-methyltetrahydrofolate Calcium Drug
FDA (Drugs) · 2016-01-13
Same hazard · foreign substance
See all →- ModerateHeritage Pharmaceuticals Recalls Clindamycin Palmitate Hydrochloride Due to Foreign Particles
FDA (Drugs) · 2026-08-19
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- ModerateCorlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
FDA (Drugs) · 2026-07-01
- LowHydroxyzine Hydrochloride Oral Solution recalled for foreign substance
FDA (Drugs) · 2026-07-01
- ModerateCorlanor ivabradine tablets recalled for presence of foreign substance
FDA (Drugs) · 2026-07-01
Similar recalls
- ModerateBaclofen USP Micronized Recalled for Lack of Stability Data
FDA (Drugs) · 2018-02-28
- HighBaclofen tablet bottles recalled over the presence of foreign tablets
FDA (Drugs) · 2025-12-24
- ModerateB&B Pharmaceuticals Recalls Estradiol Powder Due to Foreign Material
FDA (Drugs) · 2020-04-22
- ModerateAmerican Pharmaceutical Ingredients Recalls Gabapentin USP for Prescription Compounding
FDA (Drugs) · 2018-02-28
- ModerateFDA Recalls Diclofenac Sodium USP Due to Missing Stability Data
FDA (Drugs) · 2018-02-28
- SevereMylan Recalls Alprazolam Tablets Due to Foreign Substance Presence
FDA (Drugs) · 2019-11-13