Novel Laboratories Recalls Famotidine Oral Suspension Due to Impurity Failure
Novel Laboratories is recalling 25,776 containers of Famotidine Oral Suspension because the product failed an impurity specification. The recall is classified as FDA Class III.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Novel Laboratories, Inc. is recalling 25,776 containers of Famotidine for Oral Suspension, USP 40 mg/5 mL, Cherry-Banana-Mint Flavored. The product is distributed by Gavis Pharmaceuticals, LLC and is available nationwide. The recall is being conducted because the product failed an impurity/degradation specification at the 12-month stability time point.
The affected product is identified by NDC 43386-500-11. The specific lots involved are M13075A, M13076A, M13076B, M13077A, M13077B (all with expiry date 2/2015) and M13490A (with expiry date 3/2016). The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and NDC code listed above. If the product is found, it should be returned to the distributor or the manufacturer for credit. No specific instructions for immediate disposal are provided in the source text, but standard recall procedures apply.
The recalled product
- Product
- FAMOTIDINE (FAMOTIDINE)
- Brand
- FAMOTIDINE
- Manufacturer
- Novel Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 25,776
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 (5)
- Lot #'s M13075A
- M13076A
- M13076B
- M13077A
- M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
UPCs (1)
- 0343386500116
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · FAMOTIDINE
- CriticalFamotidine injection vials recalled after endotoxin results exceeded the limit
FDA (Drugs) · 2025-12-03
- ModerateFamotidine tablets recalled for carton labeling error on strength
FDA (Drugs) · 2023-07-26
- SevereAurobindo Recalls Famotidine 40mg Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2021-03-10
- LowHF Acquisition Recalls Famotidine Injection Due to Temperature Abuse
FDA (Drugs) · 2020-07-29
- LowDr. Reddy's Recalls Famotidine Tablets Due to Impurity Failure
FDA (Drugs) · 2017-10-18
Same manufacturer · Novel Laboratories, Inc.
See all →- ModerateNovel Laboratories Recalls Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
FDA (Drugs) · 2018-03-21
- LowNovel Laboratories Recalls Fluocinolone Acetonide Topical Solution Due to Chemical Contamination
FDA (Drugs) · 2017-04-19
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17